Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery

Study 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.

Official Title
-----------------
Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Drug: Vasopressin
* Drug: Phenylephrine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vasopressin<br>Low dose vasopressin as first line vasopressor in cardiac surgery. | Drug: Vasopressin<br>* Vasopressin titrated 0.01 U/min up to 0.04 U/min for MAP < 65 mmHg<br>* Other names: Pitressin;|
| Experimental: Phenylephrine<br>Low dose phenylephrine as first line vasopressor in cardiac surgery | Drug: Phenylephrine<br>* Phenylephrine titrated 0.25 mcg/kg/min up to 1.0 mcg/kg/min for MAP < 65 mmHg<br>* Other names: Neosynephrine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with acute kidney injury | KDIGO criteria | 5 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with 30-Day Mortality | Number of patients with 30-Day Mortality | 30 Days | 
| Number of patients with reoperation | Number of patients with reoperation | 5 Days | 
| Number of patients with sternal Infection | Number of patients with sternal Infection | 5 Days | 
| Number of patients with Atrial Fibrilation | Number of patients with Atrial Fibrilation | 5 Days | 
| ICU Length of Stay | Total ICU Length of Stay | 5 Days | 
| Total Vasopressor Hours | Total Vasopressor Hours | 5 Days |