A Phase 4 interventional study of Vasopressin and Phenylephrine in Acute Kidney Injury, sponsored by Thomas Jefferson University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-29.
Sponsored by Thomas Jefferson University · Phase 4, Interventional, and Prevention
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Low dose vasopressin as first line vasopressor in cardiac surgery.
Drug: Vasopressin
Low dose phenylephrine as first line vasopressor in cardiac surgery
Drug: Phenylephrine
Vasopressin titrated 0.01 U/min up to 0.04 U/min for MAP \< 65 mmHg
Also known as: Pitressin
Phenylephrine titrated 0.25 mcg/kg/min up to 1.0 mcg/kg/min for MAP \< 65 mmHg
Also known as: Neosynephrine
Number of patients with acute kidney injury
KDIGO criteria
Time frame: 5 Days
Number of patients with 30-Day Mortality
Number of patients with 30-Day Mortality
Time frame: 30 Days
Number of patients with reoperation
Number of patients with reoperation
Time frame: 5 Days
Number of patients with sternal Infection
Number of patients with sternal Infection
Time frame: 5 Days
Number of patients with Atrial Fibrilation
Number of patients with Atrial Fibrilation
Time frame: 5 Days
ICU Length of Stay
Total ICU Length of Stay
Time frame: 5 Days
Total Vasopressor Hours
Total Vasopressor Hours
Time frame: 5 Days
Plan to share: No
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Thomas Jefferson University