Trial · NCT07905963
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hierarchical composite of death, graft loss, sustained dialysis and eGFR (win ratio) | Day 30 post-transplant (dialysis assessed up to day 7; eGFR measured on days 28-35) | Each intervention participant is compared with each control participant within strata (centre, donor type), moving to the next level only if tied: (1) all-cause death (earlier is worse); (2) graft loss, defined as permanent return to dialysis or transplantectomy (earlier is worse); (3) sustained dialysis within 7 days after reperfusion, excluding a single session in the first 24 h for isolated hyperkalaemia (more sessions is worse); (4) eGFR at 1 month, CKD-EPI 2021 creatinine equation (higher is better). Reported as stratified win ratio with 95% CI (Finkelstein-Schoenfeld test), win odds and net benefit. |
| Secondary | Delayed graft function, by dialysis and functional (CRR2) definitions | Day 2 (CRR2) and up to day 7 post-transplant (dialysis) | Proportion of participants requiring any dialysis within the first 7 days after transplantation, and proportion with a creatinine reduction ratio on day 2 below 30%. |
| Secondary | Number of dialysis sessions | Up to day 7 post-transplant | Number of dialysis sessions and days to last dialysis within the first 7 days. |
| Secondary | Length of stay | Up to 90 days post-transplant | Days from transplantation to discharge from the index admission, analysed with death as a competing event. |
| Secondary | Days alive and out of hospital at 30 days | Day 30 post-transplant | Number of days alive and out of hospital within the first 30 days after transplantation. |
| Secondary | Acute pulmonary oedema | Up to day 30 post-transplant | Proportion of participants with acute pulmonary oedema, adjudicated by a blinded committee using clinical, radiological and oxygenation criteria. |
| Secondary | Cardiovascular events | Up to day 30 post-transplant | Proportion of participants with arrhythmia, acute coronary syndrome, heart failure, stroke, arterial or venous thrombosis, or major bleeding. |
| Secondary | 30-day readmission | Up to 30 days after discharge from the index admission | Proportion of participants readmitted after discharge from the index admission, by cause. |
| Secondary | BIA overhydration trajectory | Pre-transplant (0-24 h before surgery), days 1, 3 and 7, pre-discharge and month 1 post-transplant | Absolute overhydration (L) measured by bioimpedance spectroscopy at each assessment. |
| Secondary | eGFR at 3 and 12 months | Month 3 and month 12 post-transplant | Estimated glomerular filtration rate (CKD-EPI 2021 creatinine equation, mL/min/1.73 m²) obtained from medical records. |
| Secondary | Acute rejection | Up to day 30 post-transplant | Proportion of participants with biopsy-proven or presumptive acute rejection. |
| Other | Time to detection of fluid overload | From randomisation to day 7 post-transplant | Paired comparison of the time from randomisation to first detection of fluid overload by the multiparametric strategy versus physical examination, against a reference standard adjudicated by a blinded committee, with latent class analysis as a sensitivity analysis. All participants. |
| Other | Diagnostic accuracy of each method | Days 1, 3 and 7 and month 1 post-transplant | Sensitivity, specificity and likelihood ratios of bioimpedance, VExUS, graft venous pulsatility, lung ultrasound and physical examination against the adjudicated reference standard. |
| Other | Inter- and intra-observer reliability | Days 1, 3 and 7 and month 1 post-transplant | Weighted kappa, Gwet AC1/AC2 and intraclass correlation coefficient (2,1) for VExUS grade, graft venous pulsatility, lung ultrasound B-lines and bioimpedance; minimal detectable change. |
| Other | Intervention fidelity | Days 1, 3 and 7, pre-discharge and month 1 post-transplant | Proportion of assessments in the intervention arm followed by algorithm-concordant management. |
| Other | Contamination of the control arm | Day 3 and day 7 post-transplant | Cumulative intravenous fluid volume (mL) at days 3 and 7 in the control arm, compared across consecutive calendar periods of recruitment. |
| Other | Symptomatic hypotension (safety outcome) | Up to day 30 post-transplant | Proportion of participants with at least one episode of systolic blood pressure below 90 mmHg accompanied by symptoms or requiring a fluid bolus or vasopressor. |
| Other | Cumulative intravenous fluid volume and fluid balance | Day 3 and day 7 post-transplant | Total intravenous fluid volume administered (mL) and cumulative fluid balance (mL), calculated from the end of surgery. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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