Nitroglycerin Infusion During Cardiac Surgery

Blood Glucose, High Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901419
• Other study ID #: TSGHIRB 1-102-05-049
• Status: Completed
• Phase: N/A
• Start date: July 8, 2013
• Est. completion date: June 8, 2017

Study information

• Verified date: October 2020
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 8, 2017
• Est. primary completion date: June 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• elective cardiac surgery

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Acidosis
• Acidosis, Lactic
• Blood Glucose, High
• Hyperglycemia
• Lactic Acidosis

Intervention

Drug:
• Nitroglycerin infusion
Nitroglycerin infusion during rewarming

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View Citation

Piquette D, Deschamps A, Bélisle 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiac Index, Before Start of CPB	Cardiac Index, L/min/m2, Before Start of CPB	Before Start of CPB
Other	Cardiac Index, Cessation of CPB	Cardiac Index, L/min/m2, Cessation of CPB	Cessation of CPB
Other	Cardiac Index, After Protamine Administration	Cardiac Index, L/min/m2, After Protamine Administration	After Protamine Administration
Other	Cardiac Index, Upon Arrival at ICU	Cardiac Index, L/min/m2, Upon Arrival at ICU	Upon Arrival at ICU
Other	Cerebral Oximetry, Before Start of CPB, Left Forehead	Absolute Value of Cerebral Oximetry, %, Before Start of CPB, Left Forehead	Before Start of CPB
Other	Cerebral Oximetry, Before Start of CPB, Right Forehead	Absolute Value of Cerebral Oximetry, %, Before Start of CPB, Right Forehead	Before Start of CPB
Other	Cerebral Oximetry, Beginning Rewarming, Left Forehead	Absolute Value of Cerebral Oximetry, %, Beginning Rewarming, Left Forehead	Beginning Rewarming
Other	Cerebral Oximetry, Beginning Rewarming, Right Forehead	Absolute Value of Cerebral Oximetry, %, Beginning Rewarming, Right Forehead	Beginning Rewarming
Other	Cerebral Oximetry, Release of Aortic Clamp, Left Forehead	Absolute Value of Cerebral Oximetry, %, Release of Aortic Clamp, Left Forehead	Release of Aortic Clamp
Other	Cerebral Oximetry, Release of Aortic Clamp, Right Forehead	Absolute Value of Cerebral Oximetry, %, Release of Aortic Clamp, Right Forehead	Release of Aortic Clamp
Other	Cerebral Oximetry, Cessation of CPB, Left Forehead	Absolute Value of Cerebral Oximetry, %, Cessation of CPB, Left Forehead	Cessation of CPB
Other	Cerebral Oximetry, Cessation of CPB, Right Forehead	Absolute Value of Cerebral Oximetry, %, Cessation of CPB, Right Forehead	Cessation of CPB
Other	Cerebral Oximetry, After Protamine Administration, Left Forehead	Absolute Value of Cerebral Oximetry, %, After Protamine Administration, Left Forehead	After Protamine Administration
Other	Cerebral Oximetry, After Protamine Administration, Right Forehead	Absolute Value of Cerebral Oximetry, %, After Protamine Administration, Right Forehead	After Protamine Administration
Primary	Plasma Lactate Level, Before Incision	Plasma Lactate Level, mmol/L, Before Incision	Before Incision
Primary	Plasma Lactate Level, Before Start of CPB	Plasma Lactate Level, mmol/L, Before Start of CPB	Before Start of CPB
Primary	Plasma Lactate Level, Release of Aortic Clamp	Plasma Lactate Level, mmol/L, Release of Aortic Clamp	Release of Aortic Clamp
Primary	Plasma Lactate Level, After Protamine Administration	Plasma Lactate Level, mmol/L, After Cessation of CPB and Protamine Administration	After Protamine Administration
Primary	Plasma Lactate Level, Upon Arrival at ICU	Plasma Lactate Level, mmol/L, Upon Arrival at ICU	Upon Arrival at ICU
Primary	Plasma Glucose Level, Before Incision	Plasma Glucose Level, mg/dL, Before Incision	Before Incision
Primary	Plasma Glucose Level, Before Start of CPB	Plasma Glucose Level, mg/dL, Before Start of CPB	Before Start of CPB
Primary	Plasma Glucose Level, Release of Aortic Clamp	Plasma Glucose Level, mg/dL, Release of Aortic Clamp	Release of Aortic Clamp
Primary	Plasma Glucose Level, After Protamine Administration	Plasma Glucose Level, mg/dL, After Cessation of CPB and Protamine Administration	After Protamine Administration
Primary	Plasma Glucose Level, Upon Arrival at ICU	Plasma Glucose Level, mg/dL, Upon Arrival at ICU	Upon Arrival at ICU
Primary	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	Activated Coagulation Time, Before Start of CPB	Activated Coagulation Time, sec, Before Start of CPB	Before Start of CPB
Secondary	Activated Coagulation Time, After Protamine Administration	Activated Coagulation Time, sec, After Cessation of CPB and Protamine Administration	After Protamine Administration
Secondary	Post-op Dopamine Infusion	Infusion Rate of Dopamine, mcg/kg/min, Upon Arrival at ICU	Upon Arrival at ICU
Secondary	Time to Extubation	Time from Arrival at ICU to Extubation, hour	Arrival at ICU and Extubation
Secondary	Length of ICU Stay	Time from Arrival at ICU to Leaving ICU, day	Arrival at ICU and Leaving ICU