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NCT Number: NCT06487585

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Maryland St. Joseph Medical Center

Towson, Maryland, 21204, United States

Location status: Recruiting

Location contact

Rawn Salenger, MD

PRINCIPAL_INVESTIGATOR

Sam Rudow

CONTACT

[email protected]

410-427-5459

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiotensin II

Drug

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 outcomes

  1. Incidence of postoperative acute kidney injury, atrial fibrillation

    Time frame: 28 days

    The primary endpoint will be measured by comparing the incidence of new-onset atrial fibrillation or acute kidney injury

Secondary outcomes

  1. Hours on Vasopressors

    Time frame: 28 days

  2. Total IVF

    Time frame: 28 days

  3. ICU LOS

    Time frame: 28 days

  4. Postoperative LOS

    Time frame: 28 days

  5. Any major STS complication

    Time frame: 28 days

  6. 30-day mortality

    Time frame: 30 days

  7. Cost

    Time frame: 28 days

Study contacts

Contact information is provided by the study sponsor or research team.

Aja Janyavula

CONTACT

[email protected]

410-427-5459

Sam Rudow

CONTACT

[email protected]

410-427-5459

Sponsors and collaborators

Lead sponsor

University of Maryland St. Joseph Medical Center

Other

Collaborators

  • La Jolla Pharmaceutical Company

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2024
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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