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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
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
Secondary ID [1] 0 0
ACTRN12617000358347
Secondary ID [2] 0 0
15.02
Universal Trial Number (UTN)
Trial acronym
BEST-Fluids
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Disease 0 0
Delayed Graft Function 0 0
Kidney Transplant; Complications 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of participants with Delayed Graft Function
Timepoint [1] 0 0
7 Days
Secondary outcome [1] 0 0
Early Kidney Transplant Function
Timepoint [1] 0 0
a. Duration of Delayed Graft Function - 12 Weeks; b. Rate of recovery of kidney transplant graft function - 2 Days
Secondary outcome [2] 0 0
Number of dialysis sessions
Timepoint [2] 0 0
First 28 days post-transplant
Secondary outcome [3] 0 0
Total duration of dialysis
Timepoint [3] 0 0
12 Weeks
Secondary outcome [4] 0 0
Creatinine reduction ratio from day 1 to day 2 post-transplant
Timepoint [4] 0 0
Day 1 to Day 2 post-transplant
Secondary outcome [5] 0 0
Reduction in serum creatinine of greater than or equal to 10%
Timepoint [5] 0 0
First 7 days post-transplant
Secondary outcome [6] 0 0
Serum creatinine trends over 52 weeks
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Incidence of serum potassium greater than or equal to 5.5 mmol/L
Timepoint [7] 0 0
First 48 hours post-transplant
Secondary outcome [8] 0 0
Peak potassium level
Timepoint [8] 0 0
First 48 hours post-transplant
Secondary outcome [9] 0 0
Treatment for hyperkalaemia
Timepoint [9] 0 0
First 48 hours post-transplant
Secondary outcome [10] 0 0
Incidence of significant fluid overload
Timepoint [10] 0 0
Baseline to day 2
Secondary outcome [11] 0 0
Aggregate urine output
Timepoint [11] 0 0
Until day 2 post-transplant
Secondary outcome [12] 0 0
Requirement for inotropic support (use of vasopressors or other drugs to maintain adequate blood pressure)
Timepoint [12] 0 0
Intra- and post-operatively to Day 2
Secondary outcome [13] 0 0
Number of acute rejection episodes
Timepoint [13] 0 0
12 months
Secondary outcome [14] 0 0
Number of renal transplant biopsies
Timepoint [14] 0 0
First 28 days post-transplant
Secondary outcome [15] 0 0
Death from all causes
Timepoint [15] 0 0
Up to 52 weeks
Secondary outcome [16] 0 0
Graft survival
Timepoint [16] 0 0
12 months
Secondary outcome [17] 0 0
Graft function
Timepoint [17] 0 0
4, 12, 26 and 52 weeks
Secondary outcome [18] 0 0
Health-related quality of life
Timepoint [18] 0 0
Baseline, day 7, day 28, week 12, week 26, and week 52
Secondary outcome [19] 0 0
Length of hospital stay
Timepoint [19] 0 0
12 months
Secondary outcome [20] 0 0
Healthcare resource use
Timepoint [20] 0 0
12 months
Secondary outcome [21] 0 0
Cost-effectiveness
Timepoint [21] 0 0
12 months

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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
26/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/05/2022
Sample size
Target
Accrual to date
Final
808
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [4] 0 0
The Children's Hospital at Westmead - Sydney
Recruitment hospital [5] 0 0
Westmead Hospital - Sydney
Recruitment hospital [6] 0 0
Queensland Children's Hospital - Brisbane
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
St Vincent's Hospital (Melbourne) Ltd - Melbourne
Recruitment hospital [10] 0 0
Austin Health - Melbourne
Recruitment hospital [11] 0 0
Monash Children's Hospital - Melbourne
Recruitment hospital [12] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [13] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [14] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2031 - Sydney
Recruitment postcode(s) [3] 0 0
2050 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Sydney
Recruitment postcode(s) [5] 0 0
4101 - Brisbane
Recruitment postcode(s) [6] 0 0
4102 - Brisbane
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3065 - Melbourne
Recruitment postcode(s) [9] 0 0
3084 - Melbourne
Recruitment postcode(s) [10] 0 0
3168 - Melbourne
Recruitment postcode(s) [11] 0 0
6150 - Murdoch
Recruitment postcode(s) [12] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Australian Government Department of Health and Ageing
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Health Research Council, New Zealand
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Baxter Healthcare Corporation
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Collins, MBChB,FRACP,PhD
Address 0 0
Auckland District Health Board & The University of Auckland
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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.
Available to whom?
An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.
Available for what types of analyses?
How or where can data be obtained?


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