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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/NCT02020538




Registration number
NCT02020538
Ethics application status
Date submitted
19/12/2013
Date registered
25/12/2013
Date last updated
22/04/2020

Titles & IDs
Public title
Limiting IV Chloride to Reduce AKI After Cardiac Surgery
Scientific title
Does Varying the Chloride Content of Intravenous Fluid Alter the Risk of Acute Kidney Injury After Cardiac Surgery?
Secondary ID [1] 0 0
382/13
Universal Trial Number (UTN)
Trial acronym
LICRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients Undergoing Cardiothoracic Surgery 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Low-chloride perioperative intravenous fluid strategy
Other interventions - High-chloride perioperative intravenous fluid strategy

Placebo Comparator: Chloride-rich IV fluid - The chloride-rich strategy will include 0.9% saline as the perioperative crystalloid of choice with 4% albumin as the perioperative colloid of choice.

Active Comparator: Chloride-poor IV fluid - A low-chloride strategy of perioperative IV fluid will include PlasmaLyte 148 or Hartmann's solution as the crystalloid of choice with 20% albumin as the colloid of choice.


Other interventions: Low-chloride perioperative intravenous fluid strategy
The low-chloride perioperative IV fluid strategy will include the use of PlasmaLyte 148 or Hartmann's solution as the crystalloid of choice and 20% albumin as the colloid of choice.

Other interventions: High-chloride perioperative intravenous fluid strategy
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Peak ? serum creatinine
Timepoint [1] 0 0
5 days postoperatively
Primary outcome [2] 0 0
AKI =stage2
Timepoint [2] 0 0
5 days postoperatively
Secondary outcome [1] 0 0
Individual stages of AKI
Timepoint [1] 0 0
7 days
Secondary outcome [2] 0 0
Mortality
Timepoint [2] 0 0
On discharge from hospital (7-30 days)
Secondary outcome [3] 0 0
Renal replacement therapy
Timepoint [3] 0 0
On discharge from hospital (7-30 days)
Secondary outcome [4] 0 0
ICU Length of stay
Timepoint [4] 0 0
On discharge from hospital (7-30 days)
Secondary outcome [5] 0 0
Hospital Length of stay
Timepoint [5] 0 0
On discharge from hospital (7-30 days)
Secondary outcome [6] 0 0
Time to first extubation
Timepoint [6] 0 0
On discharge from hospital (7-30 days)
Secondary outcome [7] 0 0
Red cell transfusion requirement
Timepoint [7] 0 0
Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Secondary outcome [8] 0 0
Fresh frozen plasma transfusion requirement
Timepoint [8] 0 0
Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Secondary outcome [9] 0 0
Platelet transfusion requirement
Timepoint [9] 0 0
Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first
Secondary outcome [10] 0 0
Cryoprecipitate transfusion requirement
Timepoint [10] 0 0
Intraoperative and postoperatively through completion of postoperative day 1 or ICU discharge, whichever occurred first

Eligibility
Key inclusion criteria
All adult patients undergoing surgery by Division of cardiothoracic surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/02/2016
Sample size
Target
Accrual to date
Final
1298
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian and New Zealand College of Anaesthetists
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This primary aim of this study is to test the impact of a strategy of perioperative
chloride-restriction through intravenous (IV) fluid therapy on the incidence of acute kidney
injury after cardiac surgery.

A prospective, open-label, single-centre 4-period sequential study of varying strategies of
perioperative IV fluid composition will test the hypothesis that a perioperative protocol for
the administration of chloride-poor intravenous fluids compared to chloride-rich intravenous
fluids will reduce the incidence of AKI after adult cardiothoracic surgery.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02020538
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David R McIlroy, MBBS, MClinEpi, FANZCA
Address 0 0
Alfred Hospital and Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02020538