Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01901419
Other study ID # TSGHIRB 1-102-05-049
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT04854603 - Dairy Products With Reduced Sugar and Blood Glucose N/A
Not yet recruiting NCT05004558 - Effects of Remote-based Resistance Training on Cardiometabolic Risk Factors, Cognitive Function, and Quality of Life in Adults Living With Alzheimer's Disease and/or Related Dementias N/A
Not yet recruiting NCT04018430 - Impact of Oral Glucose Tolerance Test on Extent of Hemoglobin Glycation
Completed NCT03763240 - BSE on Blood Glucose N/A
Completed NCT05504096 - Calibration and Evaluation of Non-Invasive Wireless Blood Glucose Monitoring N/A
Completed NCT03686293 - A Personal Microbiome-dependent Glucose Response in Healthy Young Volunteers N/A
Completed NCT05400694 - Functional and Value-Added Dairy Products and Blood Glucose Control N/A
Terminated NCT03455985 - Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin N/A
Completed NCT05163587 - Composite Flour and Its Antdiabetic Potential N/A
Completed NCT03469869 - Effects of Balanced and Sustainable Diet Application for Insulin Resistance and Inflammation Marker of Obese People N/A
Completed NCT04961086 - Health Effect of Energy Drink Consumption N/A
Completed NCT04373863 - Assessment of Lifestyle, Blood Pressure, Cholesterol and Glycated Hemoglobin in a Specific Population
Active, not recruiting NCT04827615 - Evaluation of the Ambuja Cement Foundation Noncommunicable Disease Program in Bathinda District of Punjab, India N/A
Completed NCT04850326 - Clinical Study to Evaluate the Short Time Efficacy of AP Green Tea Extract Affer High Fat, High Carbohydrate Diet N/A
Recruiting NCT04755062 - A Culturally-relevant Micronutrient-dense Plant-rich (mNDPR) Dietary Intervention for Native Americans N/A
Not yet recruiting NCT04100369 - Admission Blood Glucose as a Predictor of Morbidity and Mortality in Polytraumatized Patients
Completed NCT03412617 - Diets, Metabolic Profile and Gut Microbiota Among Indonesian Women in Minangkabau and Sundanese-ethnic Community N/A
Completed NCT05222659 - Perioperative Glucose and Insulin Changes in Major Urologic Surgeries
Completed NCT04342624 - Investigation of Cinnamon Spice on Glucose Tolerance in Subjects With Pre-diabetes N/A
Completed NCT04446754 - The Genetic Effects of rs7903146 and Dietary Intake on Type 2 Diabetes Mellitus Risk in a Healthy Population