Recruiting

Angiotensin II

Sponsor:

University of Maryland St. Joseph Medical Center

Code:

NCT06487585

Conditions

Vasodilatory Hypotension During or After Cardiac Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Angiotensin II

Study Details

Brief summary:

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.

Conditions

Vasodilatory Hypotension During or After Cardiac Surgery

Study ID

NCT06487585

Start date

May 6, 2025

Status verified date

Dec, 2025

Completion date

Feb, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Study Drug Arm - Angiotensin II arm

Angiotensin II

Interventions

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.

Primary outcome measure

  • Incidence of postoperative acute kidney injury, atrial fibrillation [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Aja Janyavula

410-427-5459ajanyavula@umm.edu

Sam Rudow

410-427-5459samuel.rudow@umm.edu

Locations

University of Maryland St. Joseph Medical Center

Recruiting

Towson, Maryland, United States, 21204

Contacts

Sam Rudow

410-427-5459samuel.rudow@umm.edu

Principal Investigator:

Rawn Salenger, MD

More Information

Sponsor

University of Maryland St. Joseph Medical Center

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Keywords

  • Vasodilation
  • Hypotension
  • Cardiopulmonary Bypass
  • Cardiac Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland St. Joseph Medical Center on 2025-12-22.