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NCT04592744 · ClinicalTrials.gov registry record · Phase 4
Angiotensin 2 for AKI After OLT
A Phase 4 study, sponsored by University of California, Los Angeles.
- Active
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT04592744 is a Phase 4 study that is active but no longer recruiting, run by University of California, Los Angeles. The registered enrollment target is 30 participants.
The verdict
NCT04592744, a Phase 4 study, is active but no longer recruiting, sponsored by University of California, Los Angeles.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
Kidney injury is a common complication following liver transplantation and is associated with a higher complication rate and increased risk of death. While there are many factors that likely contribute to kidney injury in the perioperative period, a relative low serum level of angiotensin 2 (Ang 2) (a protein hormone that causes blood vessels to narrow) found in patients with liver cirrhosis (late stage of liver damage) may increase their risk of developing acute kidney injury (sudden episode of kidney failure or damage). We propose to investigate how early administration of Ang 2, a new vasopressor drug approved by the FDA in December 2017 for patients with low blood pressure, during the intra-operative period of liver transplant surgery affects the rate of kidney injury after transplantation. Patients who are deemed appropriate candidates for the study will be randomized 1:1 to the treatment and control groups. The intervention period of the study will occur in the operating room during transplant surgery and will be performed by their anesthesiologists. In the Treatment group, patients will receive Ang 2 infusions in addition to other standard vasopressors while patients in the control group will receive standard vasopressors alone. The infusion of Ang 2 in the treatment group will continue through the duration of the surgery and will be stopped prior to leaving the operating room. Both the treatment group and the control group will then be followed for 14 days to evaluate rates of kidney injury and to look for any complications. The follow up period will be extended to 28 days to look at in-hospital mortality rates in both groups. The daily follow up analysis will occur while the enrolled patients are inpatient following their transplantation surgery and will be done by looking at lab values and other data that is routinely gathered by their managing teams. This study will serve as a pilot study to evaluate feasibility of our protocol and to collect some prelimi
Interventions
- DRUG Norepinephrine
- DRUG Angiotensin II
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-04-08 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04592744
The ClinicalTrials.gov registry entry for NCT04592744 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Norepinephrine is the first listed.
NCT04592744 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04592744 about?
NCT04592744 is a clinical study titled "Angiotensin 2 for AKI After OLT". Kidney injury is a common complication following liver transplantation and is associated with a higher complication rate and increased risk of death. While there are many factors that likely contribute to kidney injury in the perioperative period, a relative low serum level of angiotensin 2 (Ang 2) ...
What is the current status of trial NCT04592744?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2022-04-08. Estimated completion is 2026-12.
What interventions are being tested in trial NCT04592744?
The interventions under investigation include: Norepinephrine (DRUG), Angiotensin II (DRUG).
Who is sponsoring clinical trial NCT04592744?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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