Nitroglycerin Infusion During Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nitroglycerin Infusion During Rewarming in Cardiac Surgery and Its Effects on Tissue Perfusion and Coagulation

Conditions
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Lactic Acidosis, Blood Glucose, High

Intervention / Treatment
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* Drug: Nitroglycerin infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective cardiac surgery Exclusion Criteria: heart failure, respiratory failure, asthma attack, uremia, normothermic bypass.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-dose NTG<br>Nitroglycerin infusion 1-5 mcg/kg/min | Drug: Nitroglycerin infusion<br>* Nitroglycerin infusion during rewarming<br>* Other names: Millisrol;|
| Active Comparator: Low-dose NTG<br>Nitroglycerin infusion 0-0.1 mcg/kg/min | Drug: Nitroglycerin infusion<br>* Nitroglycerin infusion during rewarming<br>* Other names: Millisrol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Lactate Level, Before Incision | Plasma Lactate Level, mmol/L, Before Incision | Before Incision | 
| Plasma Lactate Level, Before Start of CPB | Plasma Lactate Level, mmol/L, Before Start of CPB | Before Start of CPB | 
| Plasma Lactate Level, Release of Aortic Clamp | Plasma Lactate Level, mmol/L, Release of Aortic Clamp | Release of Aortic Clamp | 
| Plasma Lactate Level, After Protamine Administration | Plasma Lactate Level, mmol/L, After Cessation of CPB and Protamine Administration | After Protamine Administration | 
| Plasma Lactate Level, Upon Arrival at ICU | Plasma Lactate Level, mmol/L, Upon Arrival at ICU | Upon Arrival at ICU | 
| Plasma Glucose Level, Before Incision | Plasma Glucose Level, mg/dL, Before Incision | Before Incision | 
| Plasma Glucose Level, Before Start of CPB | Plasma Glucose Level, mg/dL, Before Start of CPB | Before Start of CPB | 
| Plasma Glucose Level, Release of Aortic Clamp | Plasma Glucose Level, mg/dL, Release of Aortic Clamp | Release of Aortic Clamp | 
| Plasma Glucose Level, After Protamine Administration | Plasma Glucose Level, mg/dL, After Cessation of CPB and Protamine Administration | After Protamine Administration | 
| Plasma Glucose Level, Upon Arrival at ICU | Plasma Glucose Level, mg/dL, Upon Arrival at ICU | 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 | After Initiation of NTG infusion During Rewarming | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activated Coagulation Time, Before Start of CPB | Activated Coagulation Time, sec, Before Start of CPB | Before Start of CPB | 
| Activated Coagulation Time, After Protamine Administration | Activated Coagulation Time, sec, After Cessation of CPB and Protamine Administration | After Protamine Administration | 
| Post-op Dopamine Infusion | Infusion Rate of Dopamine, mcg/kg/min, Upon Arrival at ICU | Upon Arrival at ICU | 
| Time to Extubation | Time from Arrival at ICU to Extubation, hour | Arrival at ICU and Extubation | 
| Length of ICU Stay | Time from Arrival at ICU to Leaving ICU, day | Arrival at ICU and Leaving ICU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nitroglycerin, cardiopulmonary bypass, cardiac surgery