Recruiting NCT06487585
ANG-First Trial (Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Angiotensin II.
- Who it may be relevant to
- Registry conditions: Vasodilatory Hypotension During or After Cardiac Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery (ANG-First Trial)
Overview
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.
Interventions
- 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.
Primary outcome measures
- Incidence of postoperative acute kidney injury, atrial fibrillation [Time frame: 28 days]
Secondary outcome measures (7)
- Hours on Vasopressors [Time frame: 28 days]
- Total IVF [Time frame: 28 days]
- ICU LOS [Time frame: 28 days]
- Postoperative LOS [Time frame: 28 days]
- Any major STS complication [Time frame: 28 days]
- 30-day mortality [Time frame: 30 days]
- Cost [Time frame: 28 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Maryland St. Joseph Medical Center — Towson
Identifiers
NCT: NCT06487585 · 00109542