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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose NTG | Experimental | Nitroglycerin infusion 1-5 mcg/kg/min |
|
| Low-dose NTG | Active Comparator | Nitroglycerin infusion 0-0.1 mcg/kg/min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitroglycerin infusion | Drug | Nitroglycerin infusion during rewarming |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Lactate Level, Before Incision | Plasma Lactate Level, mmol/L, Before Incision | Before Incision |
| Plasma Lactate Level, Before Start of CPB | Plasma Lactate Level, mmol/L, Before Start of CPB | Before Start of CPB |
| Plasma Lactate Level, Release of Aortic Clamp | Plasma Lactate Level, mmol/L, Release of Aortic Clamp | Release of Aortic Clamp |
| Plasma Lactate Level, 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 | Plasma Lactate Level, mmol/L, Upon Arrival at ICU | Upon Arrival at ICU |
| Plasma Glucose Level, Before Incision | Plasma Glucose Level, mg/dL, Before Incision | Before Incision |
| Plasma Glucose Level, Before Start of CPB | Plasma Glucose Level, mg/dL, Before Start of CPB | Before Start of CPB |
| Plasma Glucose Level, Release of Aortic Clamp | Plasma Glucose Level, mg/dL, Release of Aortic Clamp |
| Measure | Description | Time Frame |
|---|---|---|
| Activated Coagulation Time, Before Start of CPB | Activated Coagulation Time, sec, Before Start of CPB | Before Start of CPB |
| Activated Coagulation Time, After Protamine Administration | Activated Coagulation Time, sec, After Cessation of CPB and Protamine Administration |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Index, Before Start of CPB | Cardiac Index, L/min/m2, Before Start of CPB | Before Start of CPB |
| Cardiac Index, Cessation of CPB | Cardiac Index, L/min/m2, Cessation of CPB |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tso-Chou Lin, MD | Tri-Service General Hospital (TSGH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service General Hospital | Taipei | 114 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17766739 | Background | 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. | |
| 23264783 | Background | 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. |
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all IPD that underlie results in a publication are to be shared starting 6 months after journal publication.
starting 6 months after journal publication.
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.
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elective cardiac surgery
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| ID | Title | Description |
|---|---|---|
| FG000 | High-dose NTG | Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming |
| FG001 | Low-dose NTG | Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High-dose NTG | Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming |
| BG001 | Low-dose NTG | Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Lactate Level, Before Incision | Plasma Lactate Level, mmol/L, Before Incision | Posted | Mean | Standard Deviation | mmol/L | Before Incision |
|
|
30-day mortality and complications.
Re-sternotomy for bleeding; Mediastinitis with septic shock; Pneumonia; Massive hemothorax
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-dose NTG | Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Re-sternotomy for bleeding | Surgical and medical procedures | Systematic Assessment |
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One patient in NTG group experienced re-sternotomy to check bleeding in the same day and another one expired at the 25th day postoperatively due to mediastinitis with septic shock.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tso-Chou Lin | Department of Anesthesiology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan | +886-2-87927128 | tclin@mail.ndmctsgh.edu.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2016 | Feb 14, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000140 | Acidosis, Lactic |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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randomized controlled trial
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| Release of Aortic Clamp |
| Plasma Glucose Level, 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 | Plasma Glucose Level, mg/dL, Upon Arrival at ICU | 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 | After Initiation of NTG infusion During Rewarming |
| After Protamine Administration |
| Post-op Dopamine Infusion | Infusion Rate of Dopamine, mcg/kg/min, Upon Arrival at ICU | Upon Arrival at ICU |
| Time to Extubation | Time from Arrival at ICU to Extubation, hour | Arrival at ICU and Extubation |
| Length of ICU Stay | Time from Arrival at ICU to Leaving ICU, day | Arrival at ICU and Leaving ICU |
| Cessation of CPB |
| Cardiac Index, After Protamine Administration | Cardiac Index, L/min/m2, After Protamine Administration | After Protamine Administration |
| Cardiac Index, 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 | Absolute Value of Cerebral Oximetry, %, Before Start of CPB, Left Forehead | Before Start of CPB |
| Cerebral Oximetry, Before Start of CPB, Right Forehead | Absolute Value of Cerebral Oximetry, %, Before Start of CPB, Right Forehead | Before Start of CPB |
| Cerebral Oximetry, Beginning Rewarming, Left Forehead | Absolute Value of Cerebral Oximetry, %, Beginning Rewarming, Left Forehead | Beginning Rewarming |
| Cerebral Oximetry, Beginning Rewarming, Right Forehead | Absolute Value of Cerebral Oximetry, %, Beginning Rewarming, Right Forehead | Beginning Rewarming |
| Cerebral Oximetry, Release of Aortic Clamp, Left Forehead | Absolute Value of Cerebral Oximetry, %, Release of Aortic Clamp, Left Forehead | Release of Aortic Clamp |
| Cerebral Oximetry, Release of Aortic Clamp, Right Forehead | Absolute Value of Cerebral Oximetry, %, Release of Aortic Clamp, Right Forehead | Release of Aortic Clamp |
| Cerebral Oximetry, Cessation of CPB, Left Forehead | Absolute Value of Cerebral Oximetry, %, Cessation of CPB, Left Forehead | Cessation of CPB |
| Cerebral Oximetry, Cessation of CPB, Right Forehead | Absolute Value of Cerebral Oximetry, %, Cessation of CPB, Right Forehead | Cessation of CPB |
| Cerebral Oximetry, After Protamine Administration, Left Forehead | Absolute Value of Cerebral Oximetry, %, After Protamine Administration, Left Forehead | After Protamine Administration |
| Cerebral Oximetry, After Protamine Administration, Right Forehead | Absolute Value of Cerebral Oximetry, %, After Protamine Administration, Right Forehead | After Protamine Administration |
| BG002 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Plasma Lactate Level | Mean | Standard Deviation | mmol/L |
|
| Participants |
|
|
|
| Primary | Plasma Lactate Level, Before Start of CPB | Plasma Lactate Level, mmol/L, Before Start of CPB | Posted | Mean | Standard Deviation | mmol/L | Before Start of CPB |
|
|
|
|
| Primary | Plasma Lactate Level, Release of Aortic Clamp | Plasma Lactate Level, mmol/L, Release of Aortic Clamp | Posted | Mean | Standard Deviation | mmol/L | Release of Aortic Clamp |
|
|
|
|
| Primary | Plasma Lactate Level, After Protamine Administration | Plasma Lactate Level, mmol/L, After Cessation of CPB and Protamine Administration | Posted | Mean | Standard Deviation | mmol/L | After Protamine Administration |
|
|
|
|
| Primary | Plasma Lactate Level, Upon Arrival at ICU | Plasma Lactate Level, mmol/L, Upon Arrival at ICU | Posted | Mean | Standard Deviation | mmol/L | Upon Arrival at ICU |
|
|
|
|
| Primary | Plasma Glucose Level, Before Incision | Plasma Glucose Level, mg/dL, Before Incision | Posted | Mean | Standard Deviation | mg/dL | Before Incision |
|
|
|
|
| Primary | Plasma Glucose Level, Before Start of CPB | Plasma Glucose Level, mg/dL, Before Start of CPB | Posted | Mean | Standard Deviation | mg/dL | Before Start of CPB |
|
|
|
|
| Primary | Plasma Glucose Level, Release of Aortic Clamp | Plasma Glucose Level, mg/dL, Release of Aortic Clamp | Posted | Mean | Standard Deviation | mg/dL | Release of Aortic Clamp |
|
|
|
|
| Primary | Plasma Glucose Level, After Protamine Administration | Plasma Glucose Level, mg/dL, After Cessation of CPB and Protamine Administration | Posted | Mean | Standard Deviation | mg/dL | After Protamine Administration |
|
|
|
|
| Primary | Plasma Glucose Level, Upon Arrival at ICU | Plasma Glucose Level, mg/dL, Upon Arrival at ICU | Posted | Mean | Standard Deviation | mg/dL | Upon Arrival at ICU |
|
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | After Initiation of NTG infusion During Rewarming |
|
|
|
|
| Secondary | Activated Coagulation Time, Before Start of CPB | Activated Coagulation Time, sec, Before Start of CPB | Posted | Mean | Standard Deviation | second | Before Start of CPB |
|
|
|
|
| Secondary | Activated Coagulation Time, After Protamine Administration | Activated Coagulation Time, sec, After Cessation of CPB and Protamine Administration | Posted | Mean | Standard Deviation | second | After Protamine Administration |
|
|
|
|
| Secondary | Post-op Dopamine Infusion | Infusion Rate of Dopamine, mcg/kg/min, Upon Arrival at ICU | Posted | Mean | Standard Deviation | mcg/kg/min | Upon Arrival at ICU |
|
|
|
|
| Secondary | Time to Extubation | Time from Arrival at ICU to Extubation, hour | Posted | Mean | Standard Deviation | hour | Arrival at ICU and Extubation |
|
|
|
|
| Secondary | Length of ICU Stay | Time from Arrival at ICU to Leaving ICU, day | Posted | Mean | Standard Deviation | day | Arrival at ICU and Leaving ICU |
|
|
|
|
| Other Pre-specified | Cardiac Index, Before Start of CPB | Cardiac Index, L/min/m2, Before Start of CPB | Posted | Mean | Standard Deviation | L/min/m2 | Before Start of CPB |
|
|
|
|
| Other Pre-specified | Cardiac Index, Cessation of CPB | Cardiac Index, L/min/m2, Cessation of CPB | Posted | Mean | Standard Deviation | L/min/m2 | Cessation of CPB |
|
|
|
|
| Other Pre-specified | Cardiac Index, After Protamine Administration | Cardiac Index, L/min/m2, After Protamine Administration | Posted | Mean | Standard Deviation | L/min/m2 | After Protamine Administration |
|
|
|
|
| Other Pre-specified | Cardiac Index, Upon Arrival at ICU | Cardiac Index, L/min/m2, Upon Arrival at ICU | Posted | Mean | Standard Deviation | L/min/m2 | Upon Arrival at ICU |
|
|
|
|
| Other Pre-specified | Cerebral Oximetry, Before Start of CPB, Left Forehead | Absolute Value of Cerebral Oximetry, %, Before Start of CPB, Left Forehead | Posted | Mean | Standard Deviation | % of Cerebral Oximetry | Before Start of CPB |
|
|
|
|
| Other Pre-specified | Cerebral Oximetry, Before Start of CPB, Right Forehead | Absolute Value of Cerebral Oximetry, %, Before Start of CPB, Right Forehead | Posted | Mean | Standard Deviation | % of Cerebral Oximetry | Before Start of CPB |
|
|
|
|
| Other Pre-specified | Cerebral Oximetry, Beginning Rewarming, Left Forehead | Absolute Value of Cerebral Oximetry, %, Beginning Rewarming, Left Forehead | Posted | Mean | Standard Deviation | % of Cerebral Oximetry | Beginning Rewarming |
|
|
|
|
| Other Pre-specified | Cerebral Oximetry, Beginning Rewarming, Right Forehead | Absolute Value of Cerebral Oximetry, %, Beginning Rewarming, Right Forehead | Posted | Mean | Standard Deviation | % of Cerebral Oximetry | Beginning Rewarming |
|
|
|
|
| Other Pre-specified | Cerebral Oximetry, Release of Aortic Clamp, Left Forehead | Absolute Value of Cerebral Oximetry, %, Release of Aortic Clamp, Left Forehead | Posted | Mean | Standard Deviation | % of Cerebral Oximetry | Release of Aortic Clamp |
|
|
|
|
| Other Pre-specified | Cerebral Oximetry, Release of Aortic Clamp, Right Forehead | Absolute Value of Cerebral Oximetry, %, Release of Aortic Clamp, Right Forehead | Posted | Mean | Standard Deviation | % of Cerebral Oximetry | Release of Aortic Clamp |
|
|
|
|
| Other Pre-specified | Cerebral Oximetry, Cessation of CPB, Left Forehead | Absolute Value of Cerebral Oximetry, %, Cessation of CPB, Left Forehead | Posted | Mean | Standard Deviation | % of Cerebral Oximetry | Cessation of CPB |
|
|
|
|
| Other Pre-specified | Cerebral Oximetry, Cessation of CPB, Right Forehead | Absolute Value of Cerebral Oximetry, %, Cessation of CPB, Right Forehead | Posted | Mean | Standard Deviation | % of Cerebral Oximetry | Cessation of CPB |
|
|
|
|
| Other Pre-specified | Cerebral Oximetry, After Protamine Administration, Left Forehead | Absolute Value of Cerebral Oximetry, %, After Protamine Administration, Left Forehead | Posted | Mean | Standard Deviation | % of Cerebral Oximetry | After Protamine Administration |
|
|
|
|
| Other Pre-specified | Cerebral Oximetry, After Protamine Administration, Right Forehead | Absolute Value of Cerebral Oximetry, %, After Protamine Administration, Right Forehead | Posted | Mean | Standard Deviation | % of Cerebral Oximetry | After Protamine Administration |
|
|
|
|
| 1 |
| 32 |
| 2 |
| 32 |
| 0 |
| 32 |
| EG001 | Low-dose NTG | Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming | 0 | 31 | 2 | 31 | 0 | 31 |
| Mediastinitis with septic shock | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Massive hemothorax | Surgical and medical procedures | Systematic Assessment |
|
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