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Clinical Trials/NCT04602767
NCT04602767
Recruiting
Phase 4

Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery

Thomas Jefferson University1 site in 1 country300 target enrollmentOctober 15, 2020

Overview

Phase
Phase 4
Intervention
Vasopressin
Conditions
Acute Kidney Injury
Sponsor
Thomas Jefferson University
Enrollment
300
Locations
1
Primary Endpoint
Number of patients with acute kidney injury
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2020
End Date
October 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jordan Goldhammer

Associate Professor of Anesthesiology

Thomas Jefferson University

Eligibility Criteria

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

Arms & Interventions

Vasopressin

Low dose vasopressin as first line vasopressor in cardiac surgery.

Intervention: Vasopressin

Phenylephrine

Low dose phenylephrine as first line vasopressor in cardiac surgery

Intervention: Phenylephrine

Outcomes

Primary Outcomes

Number of patients with acute kidney injury

Time Frame: 5 Days

KDIGO criteria

Secondary Outcomes

  • Number of patients with 30-Day Mortality(30 Days)
  • Number of patients with reoperation(5 Days)
  • Number of patients with sternal Infection(5 Days)
  • Number of patients with Atrial Fibrilation(5 Days)
  • ICU Length of Stay(5 Days)
  • Total Vasopressor Hours(5 Days)

Study Sites (1)

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