Nitroglycerin Infusion During Cardiac Surgery

October 30, 2020 updated by: Tso-Chou Lin, MD, Tri-Service General Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective cardiac surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: High-dose NTG
Nitroglycerin infusion 1-5 mcg/kg/min
Drug: Nitroglycerin infusion
Nitroglycerin infusion during rewarming
Other Names:
  • Millisrol
ACTIVE_COMPARATOR: Low-dose NTG
Nitroglycerin infusion 0-0.1 mcg/kg/min
Drug: Nitroglycerin infusion
Nitroglycerin infusion during rewarming
Other Names:
  • Millisrol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma Lactate Level, Before Incision
Time Frame: Before Incision
Plasma Lactate Level, mmol/L, Before Incision
Before Incision
Plasma Lactate Level, Before Start of CPB
Time Frame: Before Start of CPB
Plasma Lactate Level, mmol/L, Before Start of CPB
Before Start of CPB
Plasma Lactate Level, Release of Aortic Clamp
Time Frame: Release of Aortic Clamp
Plasma Lactate Level, mmol/L, Release of Aortic Clamp
Release of Aortic Clamp
Plasma Lactate Level, After Protamine Administration
Time Frame: After Protamine Administration
Plasma Lactate Level, mmol/L, After Cessation of CPB and Protamine Administration
After Protamine Administration
Plasma Lactate Level, Upon Arrival at ICU
Time Frame: Upon Arrival at ICU
Plasma Lactate Level, mmol/L, Upon Arrival at ICU
Upon Arrival at ICU
Plasma Glucose Level, Before Incision
Time Frame: Before Incision
Plasma Glucose Level, mg/dL, Before Incision
Before Incision
Plasma Glucose Level, Before Start of CPB
Time Frame: Before Start of CPB
Plasma Glucose Level, mg/dL, Before Start of CPB
Before Start of CPB
Plasma Glucose Level, Release of Aortic Clamp
Time Frame: Release of Aortic Clamp
Plasma Glucose Level, mg/dL, Release of Aortic Clamp
Release of Aortic Clamp
Plasma Glucose Level, After Protamine Administration
Time Frame: After Protamine Administration
Plasma Glucose Level, mg/dL, After Cessation of CPB and Protamine Administration
After Protamine Administration
Plasma Glucose Level, Upon Arrival at ICU
Time Frame: Upon Arrival at ICU
Plasma Glucose Level, mg/dL, Upon Arrival at ICU
Upon Arrival at ICU
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
After Initiation of NTG infusion During Rewarming

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Activated Coagulation Time, Before Start of CPB
Time Frame: Before Start of CPB
Activated Coagulation Time, sec, Before Start of CPB
Before Start of CPB
Activated Coagulation Time, After Protamine Administration
Time Frame: After Protamine Administration
Activated Coagulation Time, sec, After Cessation of CPB and Protamine Administration
After Protamine Administration
Post-op Dopamine Infusion
Time Frame: Upon Arrival at ICU
Infusion Rate of Dopamine, mcg/kg/min, Upon Arrival at ICU
Upon Arrival at ICU
Time to Extubation
Time Frame: Arrival at ICU and Extubation
Time from Arrival at ICU to Extubation, hour
Arrival at ICU and Extubation
Length of ICU Stay
Time Frame: Arrival at ICU and Leaving ICU
Time from Arrival at ICU to Leaving ICU, day
Arrival at ICU and Leaving ICU

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiac Index, Before Start of CPB
Time Frame: Before Start of CPB
Cardiac Index, L/min/m2, Before Start of CPB
Before Start of CPB
Cardiac Index, Cessation of CPB
Time Frame: Cessation of CPB
Cardiac Index, L/min/m2, Cessation of CPB
Cessation of CPB
Cardiac Index, After Protamine Administration
Time Frame: After Protamine Administration
Cardiac Index, L/min/m2, After Protamine Administration
After Protamine Administration
Cardiac Index, Upon Arrival at ICU
Time Frame: Upon Arrival at ICU
Cardiac Index, L/min/m2, Upon Arrival at ICU
Upon Arrival at ICU
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
Before Start of CPB
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
Before Start of CPB
Cerebral Oximetry, Beginning Rewarming, Left Forehead
Time Frame: Beginning Rewarming
Absolute Value of Cerebral Oximetry, %, Beginning Rewarming, Left Forehead
Beginning Rewarming
Cerebral Oximetry, Beginning Rewarming, Right Forehead
Time Frame: Beginning Rewarming
Absolute Value of Cerebral Oximetry, %, Beginning Rewarming, Right Forehead
Beginning Rewarming
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
Release of Aortic Clamp
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
Release of Aortic Clamp
Cerebral Oximetry, Cessation of CPB, Left Forehead
Time Frame: Cessation of CPB
Absolute Value of Cerebral Oximetry, %, Cessation of CPB, Left Forehead
Cessation of CPB
Cerebral Oximetry, Cessation of CPB, Right Forehead
Time Frame: Cessation of CPB
Absolute Value of Cerebral Oximetry, %, Cessation of CPB, Right Forehead
Cessation of CPB
Cerebral Oximetry, After Protamine Administration, Left Forehead
Time Frame: After Protamine Administration
Absolute Value of Cerebral Oximetry, %, After Protamine Administration, Left Forehead
After Protamine Administration
Cerebral Oximetry, After Protamine Administration, Right Forehead
Time Frame: After Protamine Administration
Absolute Value of Cerebral Oximetry, %, After Protamine Administration, Right Forehead
After Protamine Administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tri-Service General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tso-Chou Lin, MD, Tri-Service General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 8, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 8, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 8, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TSGHIRB 1-102-05-049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication are to be shared starting 6 months after journal publication.

IPD Sharing Time Frame

starting 6 months after journal publication.

IPD Sharing Access Criteria

all IPD that underlie results in a publication are to be shared via email requests. The corresponding author will review requests and send them the supporting information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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