Acute Kidney Injury
Conditions
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.
Interventions
DRUGVasopressin
Vasopressin titrated 0.01 U/min up to 0.04 U/min for MAP \< 65 mmHg
DRUGPhenylephrine
Phenylephrine titrated 0.25 mcg/kg/min up to 1.0 mcg/kg/min for MAP \< 65 mmHg
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with acute kidney injury | 5 Days | KDIGO criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with reoperation | 5 Days | Number of patients with reoperation |
| Number of patients with sternal Infection | 5 Days | Number of patients with sternal Infection |
| Number of patients with 30-Day Mortality | 30 Days | Number of patients with 30-Day Mortality |
| ICU Length of Stay | 5 Days | Total ICU Length of Stay |
| Total Vasopressor Hours | 5 Days | Total Vasopressor Hours |
| Number of patients with Atrial Fibrilation | 5 Days | Number of patients with Atrial Fibrilation |
Countries
United States
Contacts
Primary ContactJenifer Lessin
Outcome results
None listed