Renin and Renal Biomarker Response to Angiotensin II

Alexander Flannery

Status and phase: Completed; Phase 4

Conditions: Acute Kidney Injury; Septic Shock

Treatments: Other: Standard of Care; Drug: Angiotensin II

Study type: Interventional

Funder types: Other

Identifiers

NCT04558359

57411

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Acute Kidney Injury

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 Mean Arterial Pressure = 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Standard of Care Cohort

Active Comparator group

Description:

Patients in this group will receive standard of care treatment.

Treatment:

Other: Standard of Care

Angiotensin II Cohort

Experimental group

Description:

Patients in this group will receive angiotensin II.

Treatment:

Drug: Angiotensin II