Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03829488 | Better Evidence for Selecting Transplant Fluids | PHASE3 | COMPLETED | 808 | — | — | Jan 26, 2018 | May 3, 2022 | Oct 15, 2024 | 18 | Australia, New Zealand |
Delayed Graft Function defined as receiving treatment with any form of dialysis in the first seven days after transplant
| Arm | Type | Description |
|---|---|---|
| Plasma-Lyte 148 (approx. pH 7.4) IV Infusion | EXPERIMENTAL | 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. |
| 0.9% SODIUM CHLORIDE 9g/L injection BP | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Plasma-Lyte 148 (approx. pH 7.4) IV Infusion | DRUG | 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. |
| 0.9% SODIUM CHLORIDE 9g/L injection BP | DRUG | 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. |
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 (...