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Nitroglycerin Infusion During Cardiac Surgery

Information source: Tri-Service General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lactic Acidosis; Bleeding

Intervention: Nitroglycerin infusion (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Tri-Service General Hospital

Official(s) and/or principal investigator(s):
Tso-Chou Lin, MD, Principal Investigator, Affiliation: Tri-Service General Hospital

Overall contact:
Tso-Chou Lin, MD, Phone: +886287923311, Ext: 12907, Email: tclin@ndmctsgh.edu.tw

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome:

Plasma lactate level

Perioperative blood loss

Secondary outcome:

Mean arterial blood pressure

Inotropic doses

Time to extubation

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

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- elective cardiac surgery

Exclusion Criteria:

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

Locations and Contacts

Tso-Chou Lin, MD, Phone: +886287923311, Ext: 12907, Email: tclin@ndmctsgh.edu.tw

Tri-Service General Hospital, Taipei 114, Taiwan; Recruiting
Tso-Chou Lin, Phone: +886287923311, Ext: 12907, Email: tclin@ndmctsgh.edu.tw
Tso-Chou Lin, MD, Principal Investigator
Additional Information

Related publications:

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.

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.

Starting date: July 2013
Last updated: July 13, 2013

Page last updated: August 23, 2015

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