Renin and Renal Biomarker Response to Angiotensin II

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexander Flannery
• Treatments: Angiotensin II; Angiotensinogen; Giapreza

Criteria

Inclusion Criteria:

• Medical ICU admission

• Septic shock

• Norepinephrine requirement = 0.15 mcg/kg/min for = 30 minutes (if cirrhosis, norepinephrine requirement = 0.1 mcg/kg/min for = 30 minutes)

• Kidney Disease Improving Global Outcomes stage 1 or greater AKI

Exclusion Criteria:

• Prisoner

• Pregnancy

• Acute occlusive coronary syndrome requiring intervention or acute myocardial infarction of any degree

• Purely cardiogenic shock (no distributive component)

• Mesenteric ischemia

• Acute ischemic stroke

• Hemorrhagic shock

• Active treatment of hepatorenal syndrome targeting a MAP = 65 mm Hg

• Planned withdrawal of care within next 24 hours or no escalation of care

• Patient enrolled in an interventional study

• High likelihood of medical futility in using this drug:

• 3 or more vasopressors required to sustain MAP

• Sustained norepinephrine equivalents > 0.5 mcg/kg/min

• COVID-19 positive, or high suspicion of COVID-19