drugset / Trial / NCT01901419

Nitroglycerin Infusion During Cardiac Surgery

NCT01901419 ↗

Completed 80 enrolled Tri-Service General Hospital (TSGH)
RandomizedParallel-groupDouble-blindTreatment

Summary

Hypothermic cardiopulmonary bypass results in peripheral vasoconstriction and heparin trapping. Hypoperfusion and ischemic-reperfusion injury are associated with systemic inflammatory response, while insufficient and delayed neutralization of heparin by protamine may contribute to more blood loss during rewarming stage. Nitroglycerin infusion, an NO-related vasodilator, is an established and effective treatment for unstable angina, myocardial infarction, congestive heart failure, and perioperative hemodynamic management for cardiac surgery. Therefore, we hypothesize that nitroglycerin infusion during rewarming corrects systemic ischemic stress and facilitates heparin neutralization in cardiac surgery.

Timeline

Start
2013-07-08
Primary completion
2017-06-08
Completion
2017-06-08

Outcome

Missed primary endpoint

registry analysis (superiority test); High-dose NTG vs Low-dose NTG; p = 0.618; t-test, 2 sided NCT01901419 ↗

registry COUNT_OF_PARTICIPANTS High-dose NTG: 6 Participants COUNT_OF_PARTICIPANTS Low-dose NTG: 0 Participants NCT01901419 ↗

registry analysis (superiority test); High-dose NTG vs Low-dose NTG; p <0.001; Fisher Exact NCT01901419 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitroglycerin Unknown 0.1 ug/kg —
Subject Nitroglycerin Unknown 5 ug/kg —