Nitroglycerin Infusion During Cardiac Surgery
- Conditions
- Lactic AcidosisBlood Glucose, High
- Interventions
- Registration Number
- NCT01901419
- Lead Sponsor
- Tri-Service General Hospital
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- elective cardiac surgery
- heart failure, respiratory failure, asthma attack, uremia, normothermic bypass.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-dose NTG Nitroglycerin infusion Nitroglycerin infusion 1-5 mcg/kg/min Low-dose NTG Nitroglycerin infusion Nitroglycerin infusion 0-0.1 mcg/kg/min
- Primary Outcome Measures
Name Time Method Plasma Lactate Level, Before Incision Before Incision Plasma Lactate Level, mmol/L, Before Incision
Plasma Glucose Level, Release of Aortic Clamp Release of Aortic Clamp Plasma Glucose Level, mg/dL, Release of Aortic Clamp
Plasma Lactate Level, Before Start of CPB Before Start of CPB Plasma Lactate Level, mmol/L, Before Start of CPB
Plasma Lactate Level, Release of Aortic Clamp Release of Aortic Clamp Plasma Lactate Level, mmol/L, Release of Aortic Clamp
Plasma Glucose Level, Before Incision Before Incision Plasma Glucose Level, mg/dL, Before Incision
Plasma Lactate Level, Upon Arrival at ICU Upon Arrival at ICU Plasma Lactate Level, mmol/L, Upon Arrival at ICU
Plasma Lactate Level, After Protamine Administration After Protamine Administration Plasma Lactate Level, mmol/L, After Cessation of CPB and Protamine Administration
Plasma Glucose Level, Before Start of CPB Before Start of CPB Plasma Glucose Level, mg/dL, Before Start of CPB
Plasma Glucose Level, After Protamine Administration After Protamine Administration Plasma Glucose Level, mg/dL, After Cessation of CPB and Protamine Administration
Plasma Glucose Level, Upon Arrival at ICU Upon Arrival at ICU Plasma Glucose Level, mg/dL, Upon Arrival at ICU
Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion After Initiation of NTG infusion During Rewarming Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion During Rewarming of Cardiopulmonary Bypass
- Secondary Outcome Measures
Name Time Method Activated Coagulation Time, Before Start of CPB Before Start of CPB Activated Coagulation Time, sec, Before Start of CPB
Post-op Dopamine Infusion Upon Arrival at ICU Infusion Rate of Dopamine, mcg/kg/min, Upon Arrival at ICU
Activated Coagulation Time, After Protamine Administration After Protamine Administration Activated Coagulation Time, sec, After Cessation of CPB and Protamine Administration
Length of ICU Stay Arrival at ICU and Leaving ICU Time from Arrival at ICU to Leaving ICU, day
Time to Extubation Arrival at ICU and Extubation Time from Arrival at ICU to Extubation, hour
Trial Locations
- Locations (1)
Tri-Service General Hospital
🇨🇳Taipei, Taiwan