| Trial ID: | L1414 |
| Source ID: | NCT03829488
|
| Associated Drug: |
Plasma-Lyte 148 (Approx. Ph 7.4) Iv Infusion
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| Title: |
Better Evidence for Selecting Transplant Fluids
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| Acronym: |
BEST-Fluids
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| Status: |
COMPLETED
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
End Stage Kidney Disease|Delayed Graft Function|Kidney Transplant; Complications
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| Interventions: |
DRUG: Plasma-Lyte 148 (approx. pH 7.4) IV Infusion|DRUG: 0.9% SODIUM CHLORIDE 9g/L injection BP
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| Outcome Measures: |
Primary: The proportion of participants with Delayed Graft Function, Delayed Graft Function defined as receiving treatment with any form of dialysis in the first seven days after transplant, 7 Days | Secondary: Early Kidney Transplant Function, 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)., a. Duration of Delayed Graft Function - 12 Weeks; b. Rate of recovery of kidney transplant graft function - 2 Days|Number of dialysis sessions, The number of dialysis sessions, First 28 days post-transplant|Total duration of dialysis, The total duration of dialysis in days, 12 Weeks|Creatinine reduction ratio from day 1 to day 2 post-transplant, 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, Day 1 to Day 2 post-transplant|Reduction in serum creatinine of greater than or equal to 10%, 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, First 7 days post-transplant|Serum creatinine trends over 52 weeks, Serum creatinine trends measured over 52 weeks, 12 months|Incidence of serum potassium greater than or equal to 5.5 mmol/L, Serum potassium greater than or equal to 5.5 mmol/L measured by serum assay, First 48 hours post-transplant|Peak potassium level, Peak potassium level, measured by serum assay, First 48 hours post-transplant|Treatment for hyperkalaemia, Treatment for hyperkalaemia with dialysis, Ca2+-gluconate, insulin, beta-agonists, sodium bicarbonate or ion exchange resins in the first 48 hours post-transplant, First 48 hours post-transplant|Incidence of significant fluid overload, Incidence of significant fluid overload defined as \>5% weight gain, Baseline to day 2|Aggregate urine output, Aggregate urine output until day 2 post-transplant, Until day 2 post-transplant|Requirement for inotropic support (use of vasopressors or other drugs to maintain adequate blood pressure), Requirement for inotropic support both intra- and post-operatively to Day 2, Intra- and post-operatively to Day 2|Number of acute rejection episodes, Number of acute rejection episodes in the first 52 weeks as reported by ANZDATA routine data capture and as assessed by treating physicians, 12 months|Number of renal transplant biopsies, Number of renal transplant biopsies performed in the first 28 days post-transplant, First 28 days post-transplant|Death from all causes, Death from all causes up to 52 weeks, Up to 52 weeks|Graft survival, Graft survival and death-censored graft survival as reported by ANZDATA and assessed by treating physician, 12 months|Graft function, Graft function (estimated glomerular filtration rate; eGFR) at 4, 12, 26 and 52 weeks, 4, 12, 26 and 52 weeks|Health-related quality of life, 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., Baseline, day 7, day 28, week 12, week 26, and week 52|Length of hospital stay, Length of hospital stay over 12 months using linked data state and country based health data, 12 months|Healthcare resource use, Healthcare resource use over 12 months using linked data state and country based health data, 12 months|Cost-effectiveness, Cost-effectiveness over 12 months using linked data state and country based health data, 12 months
|
| Sponsor/Collaborators: |
Sponsor: The University of Queensland | Collaborators: Australian Government Department of Health and Ageing|Health Research Council, New Zealand|Baxter Healthcare Corporation
|
| Gender: |
ALL
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| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
808
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-01-26
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| Completion Date: |
2022-05-03
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| Results First Posted: |
|
| Last Update Posted: |
2024-10-15
|
| Locations: |
Sydney Children's Hospital, Randwick, New South Wales, 2031, Australia|Prince of Wales Hospital, Sydney, New South Wales, 2031, Australia|Royal Prince Alfred Hospital, Sydney, New South Wales, 2050, Australia|The Children's Hospital at Westmead, Sydney, New South Wales, 2145, Australia|Westmead Hospital, Sydney, New South Wales, 2145, Australia|Queensland Children's Hospital, Brisbane, Queensland, 4101, Australia|Princess Alexandra Hospital, Brisbane, Queensland, 4102, Australia|Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia|St Vincent's Hospital (Melbourne) Ltd, Melbourne, Victoria, 3065, Australia|Austin Health, Melbourne, Victoria, 3084, Australia|Monash Children's Hospital, Melbourne, Victoria, 3168, Australia|Monash Medical Centre, Melbourne, Victoria, 3168, Australia|Fiona Stanley Hospital, Murdoch, Western Australia, 6150, Australia|Sir Charles Gairdner Hospital, Perth, Western Australia, 6009, Australia|Auckland City Hospital, Auckland, 1142, New Zealand|Starship Children's Hospital, Auckland, 1142, New Zealand|Christchurch Hospital, Christchurch, 8011, New Zealand|Wellington Hospital, Wellington, 6021, New Zealand
|
| URL: |
https://clinicaltrials.gov/show/NCT03829488
|
