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Nitroglycerin Infusion During Cardiac Surgery

NCT ID: NCT01901419

Last Updated: 2020-11-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-08

Study Completion Date

2017-06-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lactic Acidosis Blood Glucose, High

Keywords

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nitroglycerin cardiopulmonary bypass cardiac surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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High-dose NTG

Nitroglycerin infusion 1-5 mcg/kg/min

Group Type EXPERIMENTAL

Nitroglycerin infusion

Intervention Type DRUG

Nitroglycerin infusion during rewarming

Low-dose NTG

Nitroglycerin infusion 0-0.1 mcg/kg/min

Group Type ACTIVE_COMPARATOR

Nitroglycerin infusion

Intervention Type DRUG

Nitroglycerin infusion during rewarming

Interventions

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Nitroglycerin infusion

Nitroglycerin infusion during rewarming

Intervention Type DRUG

Other Intervention Names

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Millisrol

Eligibility Criteria

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Inclusion Criteria

* elective cardiac surgery

Exclusion Criteria

* heart failure, respiratory failure, asthma attack, uremia, normothermic bypass.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tso-Chou Lin, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tso-Chou Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Locations

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Tri-Service General Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Piquette D, Deschamps A, Belisle 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. doi: 10.1007/BF03026868.

Reference Type BACKGROUND
PMID: 17766739 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23264783 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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TSGHIRB 1-102-05-049

Identifier Type: -

Identifier Source: org_study_id