Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery

Acute Kidney Injury Clinical Trial

Official title:

Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04602767
• Other study ID #: 20D.847
• Status: Recruiting
• Phase: Phase 4
• Start date: October 15, 2020
• Est. completion date: October 1, 2024

Study information

• Verified date: March 2024
• Source: Thomas Jefferson University
• Contact: Jenifer Lessin
• Phone: 215 955-5804
• Email: jennifer.lessin[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 1, 2024
• Est. primary completion date: May 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Thomas Jefferson Univesity	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with acute kidney injury	KDIGO criteria	5 Days
Secondary	Number of patients with 30-Day Mortality	Number of patients with 30-Day Mortality	30 Days
Secondary	Number of patients with reoperation	Number of patients with reoperation	5 Days
Secondary	Number of patients with sternal Infection	Number of patients with sternal Infection	5 Days
Secondary	Number of patients with Atrial Fibrilation	Number of patients with Atrial Fibrilation	5 Days
Secondary	ICU Length of Stay	Total ICU Length of Stay	5 Days
Secondary	Total Vasopressor Hours	Total Vasopressor Hours	5 Days