Health TrialsbyHealthPanel

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

ConditionVasodilatory Hypotension During or After Cardiac Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland St. Joseph Medical Center

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Study Drug Arm - Angiotensin II armOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
28 days

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland St. Joseph Medical Center

Lead sponsor

La Jolla Pharmaceutical Company

Collaborator

Source ClinicalTrials.gov
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