Nitroglycerin Infusion During Cardiac Surgery

Tri-Service General Hospital

Status: Completed

Conditions: Blood Glucose, High; Lactic Acidosis

Treatments: Drug: Nitroglycerin infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01901419

TSGHIRB 1-102-05-049

Details and patient eligibility

About

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.

Full description

A randomized clinical trial in a tertiary academic center in patients with cardiac surgery, to receive either nitroglycerin infusion dose of 0-0.1 mcg/kg/min, or 1-5 mcg/kg/min during rewarming in cardiopulmonary bypass.

Enrollment: 80 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective cardiac surgery

Exclusion criteria

• heart failure, respiratory failure, asthma attack, uremia, normothermic bypass.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

High-dose NTG

Experimental group

Description:

Nitroglycerin infusion 1-5 mcg/kg/min

Treatment:

Drug: Nitroglycerin infusion

Low-dose NTG

Active Comparator group

Description:

Nitroglycerin infusion 0-0.1 mcg/kg/min

Treatment:

Drug: Nitroglycerin infusion