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NCT03534141 · ClinicalTrials.gov registry record · NA
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
A NA study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- NA
- Development phase
- 175
- Enrollment target
NCT03534141: Clinical Trial NA study, sponsored by University of California, San Francisco.
NCT03534141 is a NA study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 175 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03534141, a NA study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- NA
- Development phase
- 175 participants
- Enrollment target
Study Summary
Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies). Patients who experience AKI after liver transplantation have higher mortality, increased graft loss, longer hospital and intensive care unit stays, and more progression to chronic kidney disease compared with those who do not. In this study, half of the participants will have their body temperature cooled to slightly lower than normal (mild hypothermia) for a portion of the liver transplant operation, while the other half will have their body temperature maintained at normal. The study will evaluate if mild hypothermia protects from AKI during liver transplantation.
Primary Outcome
Acute Kidney Injury (AKI) is defined according to the International Club for Ascites (ICA) 2015 criteria, a revision of the Kidney Disease Improving Global Outcome (KDIGO) criteria for patients with cirrhosis (Angeli P, Ginès P, Wong F, Bernardi M, Boyer TD, Gerbes A, et al. Gut. 2015 Apr;64(4):531-7). AKI is defined as an increase in sCr ≥ 0.3 mg/dL within 48 hours, or a percentage increase ≥ 50% from baseline, or the initiation of renal replacement therapy. Baseline creatinine is defined as th
Interventions
- DEVICE Esophageal cooling/warming device
- OTHER Mild hypothermia
- OTHER Normothermia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2018-07-07 |
| Est. Completion | 2023-09-14 |
| Phase | NA |
Why NCT03534141 stopped before completion
NCT03534141 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Esophageal cooling/warming device is the first listed.
NCT03534141 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03534141 about?
NCT03534141 is a clinical study titled "Mild Hypothermia and Acute Kidney Injury in Liver Transplantation". Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies). Patients who experience AKI after liver transplantation have higher mortality, increased graft loss, longer hospital and intensive care unit stays, and more pr...
What is the current status of trial NCT03534141?
This trial is currently terminated. It is a NA study. The enrollment target is 175 participants. The study started on 2018-07-07. Estimated completion is 2023-09-14.
What interventions are being tested in trial NCT03534141?
The interventions under investigation include: Esophageal cooling/warming device (DEVICE), Mild hypothermia (OTHER), Normothermia (OTHER).
Who is sponsoring clinical trial NCT03534141?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03534141's enrollment target sits among peer trials
175 610th of 2000 higher than 1,391 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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