NCT04558359

Renin and Renal Biomarker Response to Angiotensin II

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Alexander Flannery · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Septic Shock
• Acute Kidney Injury

Interventions

Type	Name	Description
OTHER	Standard of Care	These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.
DRUG	Angiotensin II	These patients will receive angiotensin II in addition to standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.

Timeline

• Start date: 2020-10-19
• Primary completion: 2023-07-24
• Completion: 2023-07-30
• First posted: 2020-09-22
• Last updated: 2024-09-04
• Results posted: 2024-09-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study