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NCT03084666 · ClinicalTrials.gov registry record · NA
Remote Ischemic Preconditioning Living Donor Renal Transplant Protocol
A NA study, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT03084666 is a NA study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 40 participants.
The verdict
NCT03084666, a NA study, was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
In this study, patients undergoing live donor kidney transplantation will be allocated to the control group or remote ischemic preconditioning group (RIPC). RIPC is the utilization of short periods of ischemia to provide protection of the myocardium or other organ (i.e. kidney) from a subsequent ischemic event. Before allograft implantation, RIPC will be accomplished in the treatment group donor and control group donor by inducing intermittent extremity ischemia through intermittent inflation of an extremity tourniquet three times for five-minute intervals with five minutes of deflation between inflation periods. The monitored clinical end points will include total urine output following kidney reperfusion over five days, plasma creatinine declination over five days, initiation of dialysis, and development of graft injury. Magnitude of graft injury is the primary endpoint and will be measured using biochemical markers, such as, plasma and urinary concentration of neutrophil gelatinase associated lipocalin (NGAL), interleukin-18 (IL-18), and kidney injury molecule-1 (KIM-1). The sample size calculation is based on a projected difference of NGAL levels between the two study arms. Hall et al reported a mean NGAL level of 49 mg/mL (SD = 37 mg/mL) for a group of patients that had immediate graph function and a mean NGAL level of 248 mg/mL in a group of patients with slow graft function. (which Hall reference is this) Based on these data, a conservative estimate of a mean difference between study groups will be considered 35 mg/mL NGAL. Using these assumptions, an alpha level of 0.05 and 80% power, a sample size of n= 19 per study group will be calculated. By rejecting our null hypothesis, RIPC may serve as a safe, cost-effective protective strategy to prevent allograft injury in the clinical setting of live donor kidney transplantation.
Interventions
- DEVICE Zimmer ATS tourniquet system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-07-02 |
| Est. Completion | 2021-05-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03084666
The ClinicalTrials.gov registry entry for NCT03084666 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Zimmer ATS tourniquet system is the first listed.
NCT03084666 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03084666 about?
NCT03084666 is a clinical study titled "Remote Ischemic Preconditioning Living Donor Renal Transplant Protocol". In this study, patients undergoing live donor kidney transplantation will be allocated to the control group or remote ischemic preconditioning group (RIPC). RIPC is the utilization of short periods of ischemia to provide protection of the myocardium or other organ (i.e. kidney) from a subsequent isc...
What is the current status of trial NCT03084666?
This trial is currently terminated. It is a NA study. The enrollment target is 40 participants. The study started on 2014-07-02. Estimated completion is 2021-05-20.
What interventions are being tested in trial NCT03084666?
The interventions under investigation include: Zimmer ATS tourniquet system (DEVICE).
Who is sponsoring clinical trial NCT03084666?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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