Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2020
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2020
CompletedFirst Submitted
Initial submission to the registry
October 20, 2020
CompletedFirst Posted
Study publicly available on registry
October 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedMarch 29, 2024
March 1, 2024
3.6 years
October 20, 2020
March 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with acute kidney injury
KDIGO criteria
5 Days
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Vasopressin
EXPERIMENTALLow dose vasopressin as first line vasopressor in cardiac surgery.
Phenylephrine
EXPERIMENTALLow dose phenylephrine as first line vasopressor in cardiac surgery
Interventions
Vasopressin titrated 0.01 U/min up to 0.04 U/min for MAP \< 65 mmHg
Phenylephrine titrated 0.25 mcg/kg/min up to 1.0 mcg/kg/min for MAP \< 65 mmHg
Eligibility Criteria
You may qualify if:
- \>18 years of age
- Coronary artery bypass graft (CABG), valve, or combined CABG and valve surgery
You may not qualify if:
- Ejection fraction \< 35%
- \> moderate pulmonary hypertension
- \> mild right ventricular dysfunction
- Radial arterial graft
- Circulatory arrest
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas Jefferson Univesity
Philadelphia, Pennsylvania, 19146, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Anesthesiology
Study Record Dates
First Submitted
October 20, 2020
First Posted
October 26, 2020
Study Start
October 15, 2020
Primary Completion
May 29, 2024
Study Completion
October 1, 2024
Last Updated
March 29, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share