Renin and Renal Biomarker Response to Angiotensin II

NCT ID: NCT04558359

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-19
• Study Completion Date: 2023-07-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care Cohort

Patients in this group will receive standard of care treatment.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

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

Angiotensin II Cohort

Patients in this group will receive angiotensin II.

Group Type: EXPERIMENTAL

Angiotensin II

Intervention Type: DRUG

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

Interventions

Standard of Care

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

Intervention Type: OTHER

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.

Intervention Type: DRUG

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexander Flannery

OTHER

Sponsor Role: lead

Responsible Party

Alexander Flannery

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alexander H Flannery, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky HealthCare Chandler Medical Center

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

57411

Identifier Type: -

Identifier Source: org_study_id