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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03829488
Registration number
NCT03829488
Ethics application status
Date submitted
21/01/2019
Date registered
4/02/2019
Date last updated
14/12/2022
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
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).
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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Other
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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/ct2/show/NCT03829488
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Trial related presentations / publications
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03829488
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