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Nitroglycerin Infusion During Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01901419
Recruitment Status : Unknown
Verified July 2013 by Tso-Chou Lin, Tri-Service General Hospital.
Recruitment status was:  Recruiting
First Posted : July 17, 2013
Last Update Posted : July 17, 2013
Sponsor:
Information provided by (Responsible Party):
Tso-Chou Lin, Tri-Service General Hospital

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.


Condition or disease Intervention/treatment Phase
Lactic Acidosis Bleeding Drug: Nitroglycerin infusion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Nitroglycerin Infusion During Rewarming in Cardiac Surgery and Its Effects on Tissue Perfusion and Coagulation
Study Start Date : July 2013
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: High-dose NTG
Nitroglycerin infusion 1-5 mcg/kg/min
Drug: Nitroglycerin infusion
Nitroglycerin infusion during rewarming
Other Name: Millisrol

Active Comparator: Low-dose NTG
Nitroglycerin infusion 0-0.1 mcg/kg/min
Drug: Nitroglycerin infusion
Nitroglycerin infusion during rewarming
Other Name: Millisrol




Primary Outcome Measures :
  1. Plasma lactate level [ Time Frame: one year ]
  2. Perioperative blood loss [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Mean arterial blood pressure [ Time Frame: one year ]
    To keep mean blood pressure 50-80 mmHg during cardiopulmonary bypass.

  2. Inotropic doses [ Time Frame: one year ]
  3. Time to extubation [ Time Frame: one year ]

Other Outcome Measures:
  1. Brain oximetry values [ Time Frame: one year ]
    Values decreasing to 50 or less need interventions.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective cardiac surgery

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901419


Contacts
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Contact: Tso-Chou Lin, MD +886287923311 ext 12907 tclin@ndmctsgh.edu.tw

Locations
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Taiwan
Tri-Service General Hospital Recruiting
Taipei, Taiwan, 114
Contact: Tso-Chou Lin    +886287923311 ext 12907    tclin@ndmctsgh.edu.tw   
Principal Investigator: Tso-Chou Lin, MD         
Sponsors and Collaborators
Tri-Service General Hospital
Investigators
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Principal Investigator: Tso-Chou Lin, MD Tri-Service General Hospital

Publications:
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Responsible Party: Tso-Chou Lin, Assistant Professor, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT01901419     History of Changes
Other Study ID Numbers: TSGHIRB 1-102-05-049
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: July 17, 2013
Last Verified: July 2013

Keywords provided by Tso-Chou Lin, Tri-Service General Hospital:
nitroglycerin
cardiopulmonary bypass
cardiac surgery

Additional relevant MeSH terms:
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Acidosis
Acidosis, Lactic
Acid-Base Imbalance
Metabolic Diseases
Nitroglycerin
Vasodilator Agents