Trial · NCT04941911
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ability to recruit patients. | Approximately 180 days. | This will be assessed by: • Ability to recruit patients (target: ≥ 30% consent rate of eligible patients admitted for transplant) |
| Primary | Completion of the study intervention. | Approximately 9.5 hours. | This will be assessed by: • The percentage of patients successfully completing the study intervention. Defined as eligible patients who receive the entire study drug infusion in a blinded manner. |
| Secondary | The incidence of acute kidney injury. | Within 24, 72 and 168 hours post-operatively. | This will be defined by Acute Kidney Injury Network stage 1 criteria (a 50% increase in serum creatinine from baseline or less than 0.5 ml/kg/hr urine output for 6-12 hours post-transplant). |
| Secondary | Post-operative incidence of a new requirement for renal replacement therapy. | Within 24 hours, 72 hours, one and two weeks post-operatively. | Administration of haemofiltration or haemodiafiltration. |
| Secondary | Incidence of new chronic kidney disease or deterioration of chronic kidney disease. | At thirty and ninety days post operative. | This is defined as a new persistent estimated glomerular filtration rate below 60 ml/min/1.73m2 or a decline in pre-existing glomular function to a more severe KDIGO chronic kidney disease. status. |
| Secondary | Incidence of early allograft dysfunction. | At day seven post-operatively | Early allograft dysfunction defined by the presence of one or more of the following: total bilirubin ≥ 10 mg/dL (171 μmol/L) or, INR ≥ 1.6 on day 7, and ALT/AST \> 2,000 IU/L within the first 7 days post-operatively. |
| Secondary | Patient mortality. | At thirty and ninety days post-operatively. | Patient mortality at thirty and ninety days post-operatively. |
| Secondary | Intra-operative red blood cell salvage. | Within 24, 72 and 168 hours post-operatively. | Total volume of intra-operative red blood cell salvage available for reinfusion following washing and centrifugation. |
| Secondary | Volume of packed red blood cell transfusion. | Intra-operatively and at 24, 72 and 168 hours post-operatively. | Volume of packed red blood cell transfusion administered intra-operatively and at 24, 72 and 168 hours post-operatively. |
| Secondary | Incidence of adverse events secondary to study drug infusion. | Intra-operatively and up to 24 hours post-operatively. | Recorded adverse events are: abnormal QTc interval (460ms in men, 470ms in women) or associated ventricular arrhythmia or Torsades de Pointes, unexpected or resistant hypoglycaemia (blood sugar \< 4mM) and clinical suspicion of allergic or anaphylactic reaction. |
| Secondary | PROMs_ data collection_1 | For EuroQoL-5D-5, At Day 1 and at thirty and ninety days post-operatively. Then at 3, 6 & 9 months. | PROMs (Patient Recorded Outcome Measures) of quality of life . The questionnaires to be used to quantify quality of life is EuroQoL-5D-5L. |
| Secondary | PROMs_ data collection_2 | For LDQOL, At Day 1 and at thirty and ninety days post-operatively. Then at 3, 6 & 9 months. | PROMs (Patient Recorded Outcome Measures) of quality of life . The questionnaires to be used to quantify quality of life is LDQOL. |
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.
For software
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