Recruiting

Vasopressin vs. Phenylephrine

Sponsor:

Thomas Jefferson University

Code:

NCT04602767

Conditions

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vasopressin

Phenylephrine

Study Details

Brief summary:

This is a randomized, open label study to investigate vasopressin versus phenylephrine as a first line pressor in cardiac surgery. All patients >18 years of age presenting for coronary artery bypass graft (CABG), valve surgery, or combined CABG and valve surgery will be screened for inclusion. Patients with ejection fraction < 35%, > moderate pulmonary hypertension, > mild right ventricular dysfunction, a planned radial arterial graft, or circulatory arrest will be excluded. Patients will be randomized to receive either vasopressin or phenylephrine as the first line vasopressor during the perioperative period to maintain mean arterial blood pressure >65 mmhg. Primary outcome is acute kidney injury. Secondary outcomes are 30-day mortality, stroke, myocardial infarction, re-operation, sternal infection, atrial fibrillation, intensive care unit length of stay, and total vasopressor hours.

Conditions

Acute Kidney Injury

Study ID

NCT04602767

Start date

Oct 15, 2020

Status verified date

Mar, 2024

Completion date

Oct 1, 2024

Anticipated

Primary completion date

May 29, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • >18 years of age
  • Coronary artery bypass graft (CABG), valve, or combined CABG and valve surgery

Exclusion Criteria:

  • Ejection fraction < 35%
  • > moderate pulmonary hypertension
  • > mild right ventricular dysfunction
  • Radial arterial graft
  • Circulatory arrest

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Vasopressin

Low dose vasopressin as first line vasopressor in cardiac surgery.

experimental: Phenylephrine

Low dose phenylephrine as first line vasopressor in cardiac surgery

Interventions

Vasopressin

Vasopressin titrated 0.01 U/min up to 0.04 U/min for MAP < 65 mmHg

Phenylephrine

Phenylephrine titrated 0.25 mcg/kg/min up to 1.0 mcg/kg/min for MAP < 65 mmHg

Primary outcome measure

  • Number of patients with acute kidney injury [ Time Frame: 5 Days ]

Central Contacts and Locations

Central contacts

Locations

Thomas Jefferson Univesity

Recruiting

Philadelphia, Pennsylvania, United States, 19146

Contacts

Jordan Goldhammer, MD

jordan.goldhammer@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Mar 29, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2024-03-29.