Clinical trial NCT01901419: Nitroglycerin Infusion During Cardiac Surgery
Official title: Nitroglycerin Infusion During Rewarming in Cardiac Surgery and Its Effects on Tissue Perfusion and Coagulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactic Acidosis
Blood Glucose, High
Keywords: nitroglycerin
cardiopulmonary bypass
cardiac surgery
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* elective cardiac surgery

Exclusion Criteria:

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

Primary outcomes:
measure: Plasma Lactate Level, Before Incision
timeFrame: Before Incision
measure: Plasma Lactate Level, Before Start of CPB
timeFrame: Before Start of CPB
measure: Plasma Lactate Level, Release of Aortic Clamp
timeFrame: Release of Aortic Clamp
measure: Plasma Lactate Level, After Protamine Administration
timeFrame: After Protamine Administration
measure: Plasma Lactate Level, Upon Arrival at ICU
timeFrame: Upon Arrival at ICU
measure: Plasma Glucose Level, Before Incision
timeFrame: Before Incision
measure: Plasma Glucose Level, Before Start of CPB
timeFrame: Before Start of CPB
measure: Plasma Glucose Level, Release of Aortic Clamp
timeFrame: Release of Aortic Clamp
measure: Plasma Glucose Level, After Protamine Administration
timeFrame: After Protamine Administration
measure: Plasma Glucose Level, Upon Arrival at ICU
timeFrame: Upon Arrival at ICU
measure: Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion
timeFrame: After Initiation of NTG infusion During Rewarming
Secondary outcomes:
measure: Activated Coagulation Time, Before Start of CPB
timeFrame: Before Start of CPB
measure: Activated Coagulation Time, After Protamine Administration
timeFrame: After Protamine Administration
measure: Post-op Dopamine Infusion
timeFrame: Upon Arrival at ICU
measure: Time to Extubation
timeFrame: Arrival at ICU and Extubation
measure: Length of ICU Stay
timeFrame: Arrival at ICU and Leaving ICU
Other outcomes:
measure: Cardiac Index, Before Start of CPB
timeFrame: Before Start of CPB
measure: Cardiac Index, Cessation of CPB
timeFrame: Cessation of CPB
measure: Cardiac Index, After Protamine Administration
timeFrame: After Protamine Administration
measure: Cardiac Index, Upon Arrival at ICU
timeFrame: Upon Arrival at ICU
measure: Cerebral Oximetry, Before Start of CPB, Left Forehead
timeFrame: Before Start of CPB
measure: Cerebral Oximetry, Before Start of CPB, Right Forehead
timeFrame: Before Start of CPB
measure: Cerebral Oximetry, Beginning Rewarming, Left Forehead
timeFrame: Beginning Rewarming
measure: Cerebral Oximetry, Beginning Rewarming, Right Forehead
timeFrame: Beginning Rewarming
measure: Cerebral Oximetry, Release of Aortic Clamp, Left Forehead
timeFrame: Release of Aortic Clamp
measure: Cerebral Oximetry, Release of Aortic Clamp, Right Forehead
timeFrame: Release of Aortic Clamp
measure: Cerebral Oximetry, Cessation of CPB, Left Forehead
timeFrame: Cessation of CPB
measure: Cerebral Oximetry, Cessation of CPB, Right Forehead
timeFrame: Cessation of CPB
measure: Cerebral Oximetry, After Protamine Administration, Left Forehead
timeFrame: After Protamine Administration
measure: Cerebral Oximetry, After Protamine Administration, Right Forehead
timeFrame: After Protamine Administration
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
affiliation: Tri-Service General Hospital
name: Tso-Chou Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piquette D, Deschamps A, Belisle S, Pellerin M, Levesque S, Tardif JC, Denault AY. Effect of intravenous nitroglycerin on cerebral saturation in high-risk cardiac surgery. Can J Anaesth. 2007 Sep;54(9):718-27. doi: 10.1007/BF03026868.
citation: Masoumi G, Pour EH, Sadeghpour A, Ziayeefard M, Alavi M, Anbardan SJ, Shirani S. Effect of different dosages of nitroglycerin infusion on arterial blood gas tensions in patients undergoing on- pump coronary artery bypass graft surgery. J Res Med Sci. 2012 Feb;17(2):123-7.