CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Angiotensin II +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04558359
NCT04558359Phase 4Completed

Renin and Renal Biomarker Response to Angiotensin II Versus Controls in Septic Shock: An Open-Label Study

Alexander Flannery·interventional·Posted Sep 22, 2020·Updated Sep 4, 2024

In Brief

A Phase 4 clinical trial evaluating Standard of Care and Angiotensin II for Septic Shock and Acute Kidney Injury. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Septic shock continues to exert a large economic burden around the world. Several developments have occurred that lead to the current study. First, angiotensin II is the newest FDA approved vasopressor agent indicated for use in vasodilatory shock. Several subgroups from the approval trial have indicated that angiotensin II may confer a survival benefit in certain conditions, including those patients requiring continuous renal replacement therapy, those with altered angiotensin I: angiotensin II ratios, and most recently, those with elevated renin levels (which may serve as a surrogate for dysfunctional angiotensin 1: angiotensin II ratios). This open-label, sequential period pilot study will evaluate angiotensin II and biomarker response (renin) in the treatment of septic shock.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedSep 22, 2020
Enrollment StartOct 19, 2020
Primary CompletionJul 24, 2023
Study CompletionJul 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 5.8 years ago

Interventions

Standard of Careother

These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.

Angiotensin IIdrug

These patients will receive angiotensin II in addition to standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.