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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Standard of Care Cohort 		Patients in this group will receive standard of care treatment.
  • Other: Standard of Care
    These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.
Experimental
Angiotensin II Cohort 		Patients in this group will receive angiotensin II.
  • 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.

Recruiting Locations

More Details

NCT ID
NCT04558359
Status
Completed
Sponsor
Alexander Flannery

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.