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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Nitroglycerin infusion during rewarming
Tri-Service General Hospital
Taipei, Taiwan
Plasma Lactate Level, Before Incision
Plasma Lactate Level, mmol/L, Before Incision
Time frame: Before Incision
Plasma Lactate Level, Before Start of CPB
Plasma Lactate Level, mmol/L, Before Start of CPB
Time frame: Before Start of CPB
Plasma Lactate Level, Release of Aortic Clamp
Plasma Lactate Level, mmol/L, Release of Aortic Clamp
Time frame: Release of Aortic Clamp
Plasma Lactate Level, After Protamine Administration
Plasma Lactate Level, mmol/L, After Cessation of CPB and Protamine Administration
Time frame: After Protamine Administration
Plasma Lactate Level, Upon Arrival at ICU
Plasma Lactate Level, mmol/L, Upon Arrival at ICU
Time frame: Upon Arrival at ICU
Plasma Glucose Level, Before Incision
Plasma Glucose Level, mg/dL, Before Incision
Time frame: Before Incision
Plasma Glucose Level, Before Start of CPB
Plasma Glucose Level, mg/dL, Before Start of CPB
Time frame: Before Start of CPB
Plasma Glucose Level, Release of Aortic Clamp
Plasma Glucose Level, mg/dL, Release of Aortic Clamp
Time frame: Release of Aortic Clamp
Plasma Glucose Level, After Protamine Administration
Plasma Glucose Level, mg/dL, After Cessation of CPB and Protamine Administration
Time frame: After Protamine Administration
Plasma Glucose Level, Upon Arrival at ICU
Plasma Glucose Level, mg/dL, Upon Arrival at ICU
Time frame: Upon Arrival at ICU
Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion
Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion During Rewarming of Cardiopulmonary Bypass
Time frame: After Initiation of NTG infusion During Rewarming
Activated Coagulation Time, Before Start of CPB
Activated Coagulation Time, sec, Before Start of CPB
Time frame: Before Start of CPB
Activated Coagulation Time, After Protamine Administration
Activated Coagulation Time, sec, After Cessation of CPB and Protamine Administration
Time frame: After Protamine Administration
Post-op Dopamine Infusion
Infusion Rate of Dopamine, mcg/kg/min, Upon Arrival at ICU
Time frame: Upon Arrival at ICU
Time to Extubation
Time from Arrival at ICU to Extubation, hour
Time frame: Arrival at ICU and Extubation
Length of ICU Stay
Time from Arrival at ICU to Leaving ICU, day
Time frame: Arrival at ICU and Leaving ICU
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