Nitroglycerin Infusion During Cardiac Surgery
Primary Purpose
Lactic Acidosis, Blood Glucose, High
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Nitroglycerin infusion
Sponsored by
About this trial
This is an interventional treatment trial for Lactic Acidosis focused on measuring nitroglycerin, cardiopulmonary bypass, cardiac surgery
Eligibility Criteria
Inclusion Criteria:
- elective cardiac surgery
Exclusion Criteria:
- heart failure, respiratory failure, asthma attack, uremia, normothermic bypass.
Sites / Locations
- Tri-Service General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High-dose NTG
Low-dose NTG
Arm Description
Nitroglycerin infusion 1-5 mcg/kg/min
Nitroglycerin infusion 0-0.1 mcg/kg/min
Outcomes
Primary Outcome Measures
Plasma Lactate Level, Before Incision
Plasma Lactate Level, mmol/L, Before Incision
Plasma Lactate Level, Before Start of CPB
Plasma Lactate Level, mmol/L, Before Start of CPB
Plasma Lactate Level, Release of Aortic Clamp
Plasma Lactate Level, mmol/L, Release of Aortic Clamp
Plasma Lactate Level, After Protamine Administration
Plasma Lactate Level, mmol/L, After Cessation of CPB and Protamine Administration
Plasma Lactate Level, Upon Arrival at ICU
Plasma Lactate Level, mmol/L, Upon Arrival at ICU
Plasma Glucose Level, Before Incision
Plasma Glucose Level, mg/dL, Before Incision
Plasma Glucose Level, Before Start of CPB
Plasma Glucose Level, mg/dL, Before Start of CPB
Plasma Glucose Level, Release of Aortic Clamp
Plasma Glucose Level, mg/dL, Release of Aortic Clamp
Plasma Glucose Level, After Protamine Administration
Plasma Glucose Level, mg/dL, After Cessation of CPB and Protamine Administration
Plasma Glucose Level, Upon Arrival at ICU
Plasma Glucose Level, mg/dL, Upon Arrival at ICU
Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion
Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion During Rewarming of Cardiopulmonary Bypass
Secondary Outcome Measures
Activated Coagulation Time, Before Start of CPB
Activated Coagulation Time, sec, Before Start of CPB
Activated Coagulation Time, After Protamine Administration
Activated Coagulation Time, sec, After Cessation of CPB and Protamine Administration
Post-op Dopamine Infusion
Infusion Rate of Dopamine, mcg/kg/min, Upon Arrival at ICU
Time to Extubation
Time from Arrival at ICU to Extubation, hour
Length of ICU Stay
Time from Arrival at ICU to Leaving ICU, day
Full Information
NCT ID
NCT01901419
First Posted
July 10, 2013
Last Updated
October 30, 2020
Sponsor
Tri-Service General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01901419
Brief Title
Nitroglycerin Infusion During Cardiac Surgery
Official Title
Nitroglycerin Infusion During Rewarming in Cardiac Surgery and Its Effects on Tissue Perfusion and Coagulation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 8, 2013 (Actual)
Primary Completion Date
June 8, 2017 (Actual)
Study Completion Date
June 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lactic Acidosis, Blood Glucose, High
Keywords
nitroglycerin, cardiopulmonary bypass, cardiac surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-dose NTG
Arm Type
Experimental
Arm Description
Nitroglycerin infusion 1-5 mcg/kg/min
Arm Title
Low-dose NTG
Arm Type
Active Comparator
Arm Description
Nitroglycerin infusion 0-0.1 mcg/kg/min
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin infusion
Other Intervention Name(s)
Millisrol
Intervention Description
Nitroglycerin infusion during rewarming
Primary Outcome Measure Information:
Title
Plasma Lactate Level, Before Incision
Description
Plasma Lactate Level, mmol/L, Before Incision
Time Frame
Before Incision
Title
Plasma Lactate Level, Before Start of CPB
Description
Plasma Lactate Level, mmol/L, Before Start of CPB
Time Frame
Before Start of CPB
Title
Plasma Lactate Level, Release of Aortic Clamp
Description
Plasma Lactate Level, mmol/L, Release of Aortic Clamp
Time Frame
Release of Aortic Clamp
Title
Plasma Lactate Level, After Protamine Administration
Description
Plasma Lactate Level, mmol/L, After Cessation of CPB and Protamine Administration
Time Frame
After Protamine Administration
Title
Plasma Lactate Level, Upon Arrival at ICU
Description
Plasma Lactate Level, mmol/L, Upon Arrival at ICU
Time Frame
Upon Arrival at ICU
Title
Plasma Glucose Level, Before Incision
Description
Plasma Glucose Level, mg/dL, Before Incision
Time Frame
Before Incision
Title
Plasma Glucose Level, Before Start of CPB
Description
Plasma Glucose Level, mg/dL, Before Start of CPB
Time Frame
Before Start of CPB
Title
Plasma Glucose Level, Release of Aortic Clamp
Description
Plasma Glucose Level, mg/dL, Release of Aortic Clamp
Time Frame
Release of Aortic Clamp
Title
Plasma Glucose Level, After Protamine Administration
Description
Plasma Glucose Level, mg/dL, After Cessation of CPB and Protamine Administration
Time Frame
After Protamine Administration
Title
Plasma Glucose Level, Upon Arrival at ICU
Description
Plasma Glucose Level, mg/dL, Upon Arrival at ICU
Time Frame
Upon Arrival at ICU
Title
Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion
Description
Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion During Rewarming of Cardiopulmonary Bypass
Time Frame
After Initiation of NTG infusion During Rewarming
Secondary Outcome Measure Information:
Title
Activated Coagulation Time, Before Start of CPB
Description
Activated Coagulation Time, sec, Before Start of CPB
Time Frame
Before Start of CPB
Title
Activated Coagulation Time, After Protamine Administration
Description
Activated Coagulation Time, sec, After Cessation of CPB and Protamine Administration
Time Frame
After Protamine Administration
Title
Post-op Dopamine Infusion
Description
Infusion Rate of Dopamine, mcg/kg/min, Upon Arrival at ICU
Time Frame
Upon Arrival at ICU
Title
Time to Extubation
Description
Time from Arrival at ICU to Extubation, hour
Time Frame
Arrival at ICU and Extubation
Title
Length of ICU Stay
Description
Time from Arrival at ICU to Leaving ICU, day
Time Frame
Arrival at ICU and Leaving ICU
Other Pre-specified Outcome Measures:
Title
Cardiac Index, Before Start of CPB
Description
Cardiac Index, L/min/m2, Before Start of CPB
Time Frame
Before Start of CPB
Title
Cardiac Index, Cessation of CPB
Description
Cardiac Index, L/min/m2, Cessation of CPB
Time Frame
Cessation of CPB
Title
Cardiac Index, After Protamine Administration
Description
Cardiac Index, L/min/m2, After Protamine Administration
Time Frame
After Protamine Administration
Title
Cardiac Index, Upon Arrival at ICU
Description
Cardiac Index, L/min/m2, Upon Arrival at ICU
Time Frame
Upon Arrival at ICU
Title
Cerebral Oximetry, Before Start of CPB, Left Forehead
Description
Absolute Value of Cerebral Oximetry, %, Before Start of CPB, Left Forehead
Time Frame
Before Start of CPB
Title
Cerebral Oximetry, Before Start of CPB, Right Forehead
Description
Absolute Value of Cerebral Oximetry, %, Before Start of CPB, Right Forehead
Time Frame
Before Start of CPB
Title
Cerebral Oximetry, Beginning Rewarming, Left Forehead
Description
Absolute Value of Cerebral Oximetry, %, Beginning Rewarming, Left Forehead
Time Frame
Beginning Rewarming
Title
Cerebral Oximetry, Beginning Rewarming, Right Forehead
Description
Absolute Value of Cerebral Oximetry, %, Beginning Rewarming, Right Forehead
Time Frame
Beginning Rewarming
Title
Cerebral Oximetry, Release of Aortic Clamp, Left Forehead
Description
Absolute Value of Cerebral Oximetry, %, Release of Aortic Clamp, Left Forehead
Time Frame
Release of Aortic Clamp
Title
Cerebral Oximetry, Release of Aortic Clamp, Right Forehead
Description
Absolute Value of Cerebral Oximetry, %, Release of Aortic Clamp, Right Forehead
Time Frame
Release of Aortic Clamp
Title
Cerebral Oximetry, Cessation of CPB, Left Forehead
Description
Absolute Value of Cerebral Oximetry, %, Cessation of CPB, Left Forehead
Time Frame
Cessation of CPB
Title
Cerebral Oximetry, Cessation of CPB, Right Forehead
Description
Absolute Value of Cerebral Oximetry, %, Cessation of CPB, Right Forehead
Time Frame
Cessation of CPB
Title
Cerebral Oximetry, After Protamine Administration, Left Forehead
Description
Absolute Value of Cerebral Oximetry, %, After Protamine Administration, Left Forehead
Time Frame
After Protamine Administration
Title
Cerebral Oximetry, After Protamine Administration, Right Forehead
Description
Absolute Value of Cerebral Oximetry, %, After Protamine Administration, Right Forehead
Time Frame
After Protamine Administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
elective cardiac surgery
Exclusion Criteria:
heart failure, respiratory failure, asthma attack, uremia, normothermic bypass.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tso-Chou Lin, MD
Organizational Affiliation
Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
17766739
Citation
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.
Results Reference
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PubMed Identifier
23264783
Citation
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.
Results Reference
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Nitroglycerin Infusion During Cardiac Surgery
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