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Completed

NCT Number: NCT01901419

Nitroglycerin Infusion During Cardiac Surgery

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.

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Key information

Conditions

Lactic Acidosis Acid-Base Imbalance Acidosis Acidosis, Lactic Blood Glucose, High Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital

Taipei, 114, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective cardiac surgery

Exclusion criteria

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

Treatment and study plan

Nitroglycerin infusion

Drug

Nitroglycerin infusion during rewarming

Other names: Millisrol

Primary outcomes

  1. Plasma Lactate Level, Before Incision

    Time frame: Before Incision

    Plasma Lactate Level, mmol/L, Before Incision

  2. Plasma Lactate Level, Before Start of CPB

    Time frame: Before Start of CPB

    Plasma Lactate Level, mmol/L, Before Start of CPB

  3. Plasma Lactate Level, Release of Aortic Clamp

    Time frame: Release of Aortic Clamp

    Plasma Lactate Level, mmol/L, Release of Aortic Clamp

  4. Plasma Lactate Level, After Protamine Administration

    Time frame: After Protamine Administration

    Plasma Lactate Level, mmol/L, After Cessation of CPB and Protamine Administration

  5. Plasma Lactate Level, Upon Arrival at ICU

    Time frame: Upon Arrival at ICU

    Plasma Lactate Level, mmol/L, Upon Arrival at ICU

  6. Plasma Glucose Level, Before Incision

    Time frame: Before Incision

    Plasma Glucose Level, mg/dL, Before Incision

  7. Plasma Glucose Level, Before Start of CPB

    Time frame: Before Start of CPB

    Plasma Glucose Level, mg/dL, Before Start of CPB

  8. Plasma Glucose Level, Release of Aortic Clamp

    Time frame: Release of Aortic Clamp

    Plasma Glucose Level, mg/dL, Release of Aortic Clamp

  9. Plasma Glucose Level, After Protamine Administration

    Time frame: After Protamine Administration

    Plasma Glucose Level, mg/dL, After Cessation of CPB and Protamine Administration

  10. Plasma Glucose Level, Upon Arrival at ICU

    Time frame: Upon Arrival at ICU

    Plasma Glucose Level, mg/dL, Upon Arrival at ICU

  11. Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion

    Time frame: After Initiation of NTG infusion During Rewarming

    Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion During Rewarming of Cardiopulmonary Bypass

Secondary outcomes

  1. Activated Coagulation Time, Before Start of CPB

    Time frame: Before Start of CPB

    Activated Coagulation Time, sec, Before Start of CPB

  2. Activated Coagulation Time, After Protamine Administration

    Time frame: After Protamine Administration

    Activated Coagulation Time, sec, After Cessation of CPB and Protamine Administration

  3. Post-op Dopamine Infusion

    Time frame: Upon Arrival at ICU

    Infusion Rate of Dopamine, mcg/kg/min, Upon Arrival at ICU

  4. Time to Extubation

    Time frame: Arrival at ICU and Extubation

    Time from Arrival at ICU to Extubation, hour

  5. Length of ICU Stay

    Time frame: Arrival at ICU and Leaving ICU

    Time from Arrival at ICU to Leaving ICU, day

Other outcomes

  1. Cardiac Index, Before Start of CPB

    Time frame: Before Start of CPB

    Cardiac Index, L/min/m2, Before Start of CPB

  2. Cardiac Index, Cessation of CPB

    Time frame: Cessation of CPB

    Cardiac Index, L/min/m2, Cessation of CPB

  3. Cardiac Index, After Protamine Administration

    Time frame: After Protamine Administration

    Cardiac Index, L/min/m2, After Protamine Administration

  4. Cardiac Index, Upon Arrival at ICU

    Time frame: Upon Arrival at ICU

    Cardiac Index, L/min/m2, Upon Arrival at ICU

  5. Cerebral Oximetry, Before Start of CPB, Left Forehead

    Time frame: Before Start of CPB

    Absolute Value of Cerebral Oximetry, %, Before Start of CPB, Left Forehead

  6. Cerebral Oximetry, Before Start of CPB, Right Forehead

    Time frame: Before Start of CPB

    Absolute Value of Cerebral Oximetry, %, Before Start of CPB, Right Forehead

  7. Cerebral Oximetry, Beginning Rewarming, Left Forehead

    Time frame: Beginning Rewarming

    Absolute Value of Cerebral Oximetry, %, Beginning Rewarming, Left Forehead

  8. Cerebral Oximetry, Beginning Rewarming, Right Forehead

    Time frame: Beginning Rewarming

    Absolute Value of Cerebral Oximetry, %, Beginning Rewarming, Right Forehead

  9. Cerebral Oximetry, Release of Aortic Clamp, Left Forehead

    Time frame: Release of Aortic Clamp

    Absolute Value of Cerebral Oximetry, %, Release of Aortic Clamp, Left Forehead

  10. Cerebral Oximetry, Release of Aortic Clamp, Right Forehead

    Time frame: Release of Aortic Clamp

    Absolute Value of Cerebral Oximetry, %, Release of Aortic Clamp, Right Forehead

  11. Cerebral Oximetry, Cessation of CPB, Left Forehead

    Time frame: Cessation of CPB

    Absolute Value of Cerebral Oximetry, %, Cessation of CPB, Left Forehead

  12. Cerebral Oximetry, Cessation of CPB, Right Forehead

    Time frame: Cessation of CPB

    Absolute Value of Cerebral Oximetry, %, Cessation of CPB, Right Forehead

  13. Cerebral Oximetry, After Protamine Administration, Left Forehead

    Time frame: After Protamine Administration

    Absolute Value of Cerebral Oximetry, %, After Protamine Administration, Left Forehead

  14. Cerebral Oximetry, After Protamine Administration, Right Forehead

    Time frame: After Protamine Administration

    Absolute Value of Cerebral Oximetry, %, After Protamine Administration, Right Forehead

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 17, 2013
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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