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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03829488
Registration number
NCT03829488
Ethics application status
Date submitted
21/01/2019
Date registered
4/02/2019
Titles & IDs
Public title
Better Evidence for Selecting Transplant Fluids
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Scientific title
An Investigator-initiated, Pragmatic, Registry-based, Multi-centre, Double-blind, Randomised Controlled Trial Evaluating the Effect of Plasmalyte Versus 0.9% Saline on Early Kidney Transplant Function in Deceased Donor Kidney Transplantation
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Secondary ID [1]
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ACTRN12617000358347
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Secondary ID [2]
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15.02
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Universal Trial Number (UTN)
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Trial acronym
BEST-Fluids
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Disease
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Delayed Graft Function
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Kidney Transplant; Complications
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Plasma-Lyte 148 (approx. pH 7.4) IV Infusion
Treatment: Drugs - 0.9% SODIUM CHLORIDE 9g/L injection BP
Experimental: Plasma-Lyte 148 (approx. pH 7.4) IV Infusion - Plasma-Lyte 148 (approx. pH 7.4) IV Infusion intravenous fluid therapy will be used for all maintenance, replacement and resuscitation purposes from randomization onwards until 48 hours post-transplant, or until fluid therapy is no longer required, if earlier.
Active comparator: 0.9% SODIUM CHLORIDE 9g/L injection BP - 0.9% saline intravenous fluid therapy will be used for all maintenance, replacement and resuscitation purposes from randomization onwards until 48 hours post-transplant, or until fluid therapy is no longer required, if earlier.
Treatment: Drugs: Plasma-Lyte 148 (approx. pH 7.4) IV Infusion
Plasma-Lyte 148 (approx. pH 7.4) IV Infusion is a sterile, clear, non-pyrogenic isotonic solution and when administered intravenously is a source of water, electrolytes and calories. Plasma-Lyte 148 intravenous infusion is indicated as a source of water \& electrolytes or as an alkalinising agent.
Treatment: Drugs: 0.9% SODIUM CHLORIDE 9g/L injection BP
Sodium chloride (0.9% saline) infusion is a sterile, non-pyrogenic solution of sodium chloride in Water for Injections. The concentration of sodium chloride is 154mmol/L. Sodium chloride (0.9%) intravenous infusion is indicated for extra-cellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium and chloride ions.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The proportion of participants with Delayed Graft Function
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Assessment method [1]
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Delayed Graft Function defined as receiving treatment with any form of dialysis in the first seven days after transplant
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Timepoint [1]
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7 Days
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Secondary outcome [1]
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Early Kidney Transplant Function
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Assessment method [1]
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Early Kidney Transplant Function, a ranked composite of
1. Duration of Delayed Graft Function Description: Participants who require dialysis within seven days post-transplant, the time from transplant to the final dialysis treatment in days (up to 84 days/12 weeks) will be ranked from best to worst (longer times are worse).
2. Rate of recovery of kidney transplant graft function Description: for participants who do not require dialysis, graft function assessed using the creatinine reduction ratio on post-transplant day two (CRR2) will be ranked from best to worst (smaller reductions are worse).
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Timepoint [1]
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a. Duration of Delayed Graft Function - 12 Weeks; b. Rate of recovery of kidney transplant graft function - 2 Days
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Secondary outcome [2]
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Number of dialysis sessions
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Assessment method [2]
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The number of dialysis sessions
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Timepoint [2]
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First 28 days post-transplant
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Secondary outcome [3]
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Total duration of dialysis
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Assessment method [3]
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The total duration of dialysis in days
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Timepoint [3]
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12 Weeks
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Secondary outcome [4]
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Creatinine reduction ratio from day 1 to day 2 post-transplant
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Assessment method [4]
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Creatinine reduction ratio from day one to day two measured using serum assay, for those who do not require dialysis within the first 7 days
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Timepoint [4]
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Day 1 to Day 2 post-transplant
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Secondary outcome [5]
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Reduction in serum creatinine of greater than or equal to 10%
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Assessment method [5]
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The proportion of subjects with a reduction in serum creatinine of greater than or equal to 10% on three consecutive days in the first 7 days post-transplant
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Timepoint [5]
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First 7 days post-transplant
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Secondary outcome [6]
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Serum creatinine trends over 52 weeks
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Assessment method [6]
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Serum creatinine trends measured over 52 weeks
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Timepoint [6]
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12 months
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Secondary outcome [7]
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Incidence of serum potassium greater than or equal to 5.5 mmol/L
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Assessment method [7]
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Serum potassium greater than or equal to 5.5 mmol/L measured by serum assay
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Timepoint [7]
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First 48 hours post-transplant
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Secondary outcome [8]
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Peak potassium level
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Assessment method [8]
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Peak potassium level, measured by serum assay
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Timepoint [8]
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First 48 hours post-transplant
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Secondary outcome [9]
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Treatment for hyperkalaemia
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Assessment method [9]
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Treatment for hyperkalaemia with dialysis, Ca2+-gluconate, insulin, beta-agonists, sodium bicarbonate or ion exchange resins in the first 48 hours post-transplant
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Timepoint [9]
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First 48 hours post-transplant
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Secondary outcome [10]
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Incidence of significant fluid overload
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Assessment method [10]
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Incidence of significant fluid overload defined as \>5% weight gain
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Timepoint [10]
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Baseline to day 2
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Secondary outcome [11]
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Aggregate urine output
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Assessment method [11]
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Aggregate urine output until day 2 post-transplant
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Timepoint [11]
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Until day 2 post-transplant
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Secondary outcome [12]
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Requirement for inotropic support (use of vasopressors or other drugs to maintain adequate blood pressure)
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Assessment method [12]
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Requirement for inotropic support both intra- and post-operatively to Day 2
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Timepoint [12]
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Intra- and post-operatively to Day 2
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Secondary outcome [13]
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Number of acute rejection episodes
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Assessment method [13]
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Number of acute rejection episodes in the first 52 weeks as reported by ANZDATA routine data capture and as assessed by treating physicians
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Timepoint [13]
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12 months
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Secondary outcome [14]
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Number of renal transplant biopsies
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Assessment method [14]
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Number of renal transplant biopsies performed in the first 28 days post-transplant
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Timepoint [14]
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First 28 days post-transplant
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Secondary outcome [15]
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Death from all causes
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Assessment method [15]
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Death from all causes up to 52 weeks
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Timepoint [15]
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Up to 52 weeks
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Secondary outcome [16]
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Graft survival
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Assessment method [16]
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Graft survival and death-censored graft survival as reported by ANZDATA and assessed by treating physician
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Timepoint [16]
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12 months
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Secondary outcome [17]
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Graft function
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Assessment method [17]
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Graft function (estimated glomerular filtration rate; eGFR) at 4, 12, 26 and 52 weeks
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Timepoint [17]
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4, 12, 26 and 52 weeks
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Secondary outcome [18]
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Health-related quality of life
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Assessment method [18]
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Health-related quality of life measured using EuroQol EQ-5D-5L for adults, and EQ-5D-Y in children under 18 years. EQ-5D has descriptive and visual analogue scale (VAS). Descriptive system consists of five dimensions mobility, self-care, usual activities, pain/discomfort and anxiety/depression. VAS records patient's self-rated health on vertical visual analogue scale with endpoints best to worst health with 0 being worst and 100 being best health.
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Timepoint [18]
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Baseline, day 7, day 28, week 12, week 26, and week 52
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Secondary outcome [19]
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Length of hospital stay
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Assessment method [19]
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Length of hospital stay over 12 months using linked data state and country based health data
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Timepoint [19]
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12 months
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Secondary outcome [20]
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Healthcare resource use
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Assessment method [20]
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Healthcare resource use over 12 months using linked data state and country based health data
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Timepoint [20]
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12 months
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Secondary outcome [21]
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Cost-effectiveness
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Assessment method [21]
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Cost-effectiveness over 12 months using linked data state and country based health data
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Timepoint [21]
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12 months
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Eligibility
Key inclusion criteria
1. Adult or child with End-Stage Kidney Disease, of any cause, on maintenance dialysis, or who has pre-dialysis stage 5 chronic kidney disease with an estimated Glomerular Filtration Rate of <15 mL/min/1.73m2, AND
2. Planned deceased donor kidney transplant from a brain-death (DBD) or circulatory-death (DCD) organ donor within 24 hours, AND
3. Written informed consent, or consent given by their parent or guardian (if age <18), or other authorised person
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Planned live donor kidney transplant (except where this is cancelled in favour or transplantation from a deceased donor)
2. Planned multi-organ transplant (dual or en-bloc kidney transplants are not excluded)
3. Children of weight <20 kg, or a child that the treating physician believes should not be included in a study of blinded fluids due to their small body size
4. Known hypersensitivity to the trial fluid preparations or packaging
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/01/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/05/2022
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Sample size
Target
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Accrual to date
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Final
808
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Sydney Children's Hospital - Randwick
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Recruitment hospital [2]
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Prince of Wales Hospital - Sydney
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Recruitment hospital [3]
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Royal Prince Alfred Hospital - Sydney
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Recruitment hospital [4]
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The Children's Hospital at Westmead - Sydney
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Recruitment hospital [5]
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Westmead Hospital - Sydney
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Recruitment hospital [6]
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Queensland Children's Hospital - Brisbane
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Recruitment hospital [7]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [8]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [9]
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St Vincent's Hospital (Melbourne) Ltd - Melbourne
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Recruitment hospital [10]
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Austin Health - Melbourne
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Recruitment hospital [11]
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Monash Children's Hospital - Melbourne
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Recruitment hospital [12]
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Monash Medical Centre - Melbourne
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Recruitment hospital [13]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [14]
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Sir Charles Gairdner Hospital - Perth
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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2031 - Sydney
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Recruitment postcode(s) [3]
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2050 - Sydney
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Recruitment postcode(s) [4]
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2145 - Sydney
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Recruitment postcode(s) [5]
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4101 - Brisbane
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Recruitment postcode(s) [6]
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4102 - Brisbane
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Recruitment postcode(s) [7]
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5000 - Adelaide
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Recruitment postcode(s) [8]
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3065 - Melbourne
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Recruitment postcode(s) [9]
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3084 - Melbourne
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Recruitment postcode(s) [10]
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3168 - Melbourne
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Recruitment postcode(s) [11]
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6150 - Murdoch
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Recruitment postcode(s) [12]
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6009 - Perth
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Country [3]
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New Zealand
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State/province [3]
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Wellington
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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Australian Government Department of Health and Ageing
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Health Research Council, New Zealand
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Address [2]
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Country [2]
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Other collaborator category [3]
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Commercial sector/industry
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Name [3]
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Baxter Healthcare Corporation
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
End-stage kidney disease (ESKD) is a significant, expensive health problem. Kidney transplantation improves survival, quality of life, and is much cheaper than dialysis treatment for ESKD. However sometimes kidney transplants from a deceased donor function poorly after surgery, and a period of continued dialysis is needed, a condition known as delayed graft function (DGF). In addition to complicating recovery, DGF can adversely affect long-term kidney function and the health of the recipient. Intravenous fluids given during and after transplantation (usually 0.9% sodium chloride or saline) are critical to preserve kidney transplant function, but there is evidence that 0.9% saline may not be the safest fluid to use due to its high chloride content. BEST Fluids is a randomised controlled trial that aims to find out whether using a balanced low-chloride solution - Plasma-Lyte 148® - as an alternative to normal saline in deceased donor kidney transplantation, will improve kidney transplant function, reduce the impact of DGF, and improve long-term outcomes for patients.
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Trial website
https://clinicaltrials.gov/study/NCT03829488
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Trial related presentations / publications
Pascoe EM, Chadban SJ, Fahim MA, Hawley CM, Johnson DW, Collins MG; BEST-fluids Investigators and the Australasian Kidney Trials Network. Statistical analysis plan for Better Evidence for Selecting Transplant Fluids (BEST-Fluids): a randomised controlled trial of the effect of intravenous fluid therapy with balanced crystalloid versus saline on the incidence of delayed graft function in deceased donor kidney transplantation. Trials. 2022 Jan 18;23(1):52. doi: 10.1186/s13063-021-05989-w. Erratum In: Trials. 2022 Feb 7;23(1):123. doi: 10.1186/s13063-022-06050-0. Collins MG, Fahim MA, Pascoe EM, Dansie KB, Hawley CM, Clayton PA, Howard K, Johnson DW, McArthur CJ, McConnochie RC, Mount PF, Reidlinger D, Robison L, Varghese J, Vergara LA, Weinberg L, Chadban SJ; BEST-Fluids Investigators and the Australasian Kidney Trials Network. Study Protocol for Better Evidence for Selecting Transplant Fluids (BEST-Fluids): a pragmatic, registry-based, multi-center, double-blind, randomized controlled trial evaluating the effect of intravenous fluid therapy with Plasma-Lyte 148 versus 0.9% saline on delayed graft function in deceased donor kidney transplantation. Trials. 2020 May 25;21(1):428. doi: 10.1186/s13063-020-04359-2.
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Public notes
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Contacts
Principal investigator
Name
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Michael Collins, MBChB,FRACP,PhD
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Address
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Auckland District Health Board & The University of Auckland
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Yes Individual participant data that underlie the results reported in the primary publication, after de-identification (text, tables, figures and appendices) will be available for individual participant data meta-analysis.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
Beginning 2 years and ending 5 years following main publication. Proposals may be submitted up to 5 years following article publication. After 5 years, the data will be available in our University's data warehouse but without investigator support other than deposited metadata.
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Available to whom?
An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03829488