ANG-First Trial (Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery)

Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery (ANG-First Trial)

The purpose of this research is to evaluate the use of Angiotensin II in patients with low blood pressure post-surgery. Your information will be collected for 28 days post the procedure and initiation of the study drug to assess for safety events and complications.

Study Overview

• Status: Recruiting
• Conditions: Vasodilatory Hypotension During or After Cardiac Surgery
• Intervention / Treatment: Drug: Angiotensin II

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Aja Janyavula; Phone Number: 410-427-5459; Email: ajanyavula@umm.edu
• Study Contact Backup: Name: Sam Rudow; Phone Number: 410-427-5459; Email: samuel.rudow@umm.edu

Study Locations

• United States
  • Maryland
    • Towson, Maryland, United States, 21204
      • Recruiting
      • University of Maryland St. Joseph Medical Center
      • Contact: Sam Rudow; Phone Number: 410-427-5459; Email: samuel.rudow@umm.edu
      • Principal Investigator: Rawn Salenger, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult patients ≥ 18 years of age undergoing cardiac surgery requiring CPB
• Patients must have clinical features of vasodilation as determined by a MAP < 65 mmHg that is non-transient in the opinion of the treating physician
• Patients must be adequately volume resuscitated in the opinion of the treating physician
• Systemic Vascular Resistance index (SVRi) < 1970 dynes·sec/cm⁵/m² to support the clinical diagnosis of vasodilation; if no pulmonary artery catheter is in place, vasodilatory hypotension diagnosis according to the judgement of the critical care team
• Biventricular systolic function is at or greater than pre-cardiopulmonary bypass baseline as demonstrated by echocardiographic evaluation, or the patient is concomitantly treated with

Exclusion Criteria:

• Bleeding as primary etiology of hypotension, as determined by > 4 units RBC transfusion in 24 hours.
• Patients on ECMO
• Patients with active endocarditis
• Patients already on renal replacement therapy or creatinine of > 4 mg/dl within 2 weeks of surgery
• Patients with contraindications to Angiotensin II including women who are pregnant or breastfeeding or have active coronary ischemia, mesenteric ischemia, limb ischemia, or high potassium (> 5.5 meq/L) while receiving Angiotensin II

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study Drug Arm - Angiotensin II arm; Angiotensin II	Drug: Angiotensin II; Angiotensin II: Starting dose of 2.5 ng/kg/min administered IV; may dose escalate up to 80 ng/kg/min in order to achieve a MAP of 65 mmHg or higher in the first 3 hours. After 3 hours, may escalate dose up to 40 ng/kg/min in order to achieve a MAP of 65 mmHg. Dose titration in increments of 10 ng/kg/min every 2 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative acute kidney injury, atrial fibrillation	The primary endpoint will be measured by comparing the incidence of new-onset atrial fibrillation or acute kidney injury	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
30-day mortality	30 days
Hours on Vasopressors	28 days
Total IVF	28 days
ICU LOS	28 days
Postoperative LOS	28 days
Any major STS complication	28 days
Cost	28 days

Collaborators and Investigators

• Sponsor: University of Maryland St. Joseph Medical Center
• Collaborators: La Jolla Pharmaceutical Company

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Hypotension; Cardiac Surgery; Vasodilation; Cardiopulmonary Bypass
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension; Aneurysm; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Biological Factors; Autacoids; Inflammation Mediators; Angiotensins; Angiotensin II
• Other Study ID Numbers: 00109542

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes