Blood Glucose, High, Lactic Acidosis
Conditions
Keywords
nitroglycerin, cardiopulmonary bypass, cardiac surgery
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.
Interventions
Nitroglycerin infusion during rewarming
Sponsors
Tri-Service General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* elective cardiac surgery
Exclusion criteria
* heart failure, respiratory failure, asthma attack, uremia, normothermic bypass.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Lactate Level, Before Incision | Before Incision | Plasma Lactate Level, mmol/L, Before Incision |
| Plasma Lactate Level, Before Start of CPB | Before Start of CPB | Plasma Lactate Level, mmol/L, Before Start of CPB |
| Plasma Lactate Level, Release of Aortic Clamp | Release of Aortic Clamp | Plasma Lactate Level, mmol/L, Release of Aortic Clamp |
| Plasma Lactate Level, After Protamine Administration | After Protamine Administration | Plasma Lactate Level, mmol/L, After Cessation of CPB and Protamine Administration |
| Plasma Lactate Level, Upon Arrival at ICU | Upon Arrival at ICU | Plasma Lactate Level, mmol/L, Upon Arrival at ICU |
| Plasma Glucose Level, Before Incision | Before Incision | Plasma Glucose Level, mg/dL, Before Incision |
| Plasma Glucose Level, Before Start of CPB | Before Start of CPB | Plasma Glucose Level, mg/dL, Before Start of CPB |
| Plasma Glucose Level, Release of Aortic Clamp | Release of Aortic Clamp | Plasma Glucose Level, mg/dL, Release of Aortic Clamp |
| Plasma Glucose Level, After Protamine Administration | After Protamine Administration | Plasma Glucose Level, mg/dL, After Cessation of CPB and Protamine Administration |
| Plasma Glucose Level, Upon Arrival at ICU | Upon Arrival at ICU | Plasma Glucose Level, mg/dL, Upon Arrival at ICU |
| Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion | After Initiation of NTG infusion During Rewarming | Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion During Rewarming of Cardiopulmonary Bypass |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU Stay | Arrival at ICU and Leaving ICU | Time from Arrival at ICU to Leaving ICU, day |
| Activated Coagulation Time, Before Start of CPB | Before Start of CPB | Activated Coagulation Time, sec, Before Start of CPB |
| Activated Coagulation Time, After Protamine Administration | After Protamine Administration | Activated Coagulation Time, sec, After Cessation of CPB and Protamine Administration |
| Post-op Dopamine Infusion | Upon Arrival at ICU | Infusion Rate of Dopamine, mcg/kg/min, Upon Arrival at ICU |
| Time to Extubation | Arrival at ICU and Extubation | Time from Arrival at ICU to Extubation, hour |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Oximetry, Before Start of CPB, Right Forehead | Before Start of CPB | Absolute Value of Cerebral Oximetry, %, Before Start of CPB, Right Forehead |
| Cerebral Oximetry, Beginning Rewarming, Left Forehead | Beginning Rewarming | Absolute Value of Cerebral Oximetry, %, Beginning Rewarming, Left Forehead |
| Cerebral Oximetry, Beginning Rewarming, Right Forehead | Beginning Rewarming | Absolute Value of Cerebral Oximetry, %, Beginning Rewarming, Right Forehead |
| Cerebral Oximetry, Release of Aortic Clamp, Left Forehead | Release of Aortic Clamp | Absolute Value of Cerebral Oximetry, %, Release of Aortic Clamp, Left Forehead |
| Cerebral Oximetry, Release of Aortic Clamp, Right Forehead | Release of Aortic Clamp | Absolute Value of Cerebral Oximetry, %, Release of Aortic Clamp, Right Forehead |
| Cerebral Oximetry, Cessation of CPB, Left Forehead | Cessation of CPB | Absolute Value of Cerebral Oximetry, %, Cessation of CPB, Left Forehead |
| Cerebral Oximetry, Cessation of CPB, Right Forehead | Cessation of CPB | Absolute Value of Cerebral Oximetry, %, Cessation of CPB, Right Forehead |
| Cerebral Oximetry, After Protamine Administration, Left Forehead | After Protamine Administration | Absolute Value of Cerebral Oximetry, %, After Protamine Administration, Left Forehead |
| Cerebral Oximetry, After Protamine Administration, Right Forehead | After Protamine Administration | Absolute Value of Cerebral Oximetry, %, After Protamine Administration, Right Forehead |
| Cardiac Index, Before Start of CPB | Before Start of CPB | Cardiac Index, L/min/m2, Before Start of CPB |
| Cardiac Index, Cessation of CPB | Cessation of CPB | Cardiac Index, L/min/m2, Cessation of CPB |
| Cardiac Index, After Protamine Administration | After Protamine Administration | Cardiac Index, L/min/m2, After Protamine Administration |
| Cardiac Index, Upon Arrival at ICU | Upon Arrival at ICU | Cardiac Index, L/min/m2, Upon Arrival at ICU |
| Cerebral Oximetry, Before Start of CPB, Left Forehead | Before Start of CPB | Absolute Value of Cerebral Oximetry, %, Before Start of CPB, Left Forehead |
Countries
Taiwan
Participant flow
Recruitment details
elective cardiac surgery
Participants by arm
| Arm | Count |
|---|---|
| High-dose NTG Nitroglycerin infusion 1-5 mcg/kg/min
Nitroglycerin infusion: Nitroglycerin infusion during rewarming | 32 |
| Low-dose NTG Nitroglycerin infusion 0-0.1 mcg/kg/min
Nitroglycerin infusion: Nitroglycerin infusion during rewarming | 31 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 6 |
| Overall Study | unavailable researchers | 6 | 3 |
Baseline characteristics
| Characteristic | High-dose NTG | Low-dose NTG | Total |
|---|---|---|---|
| Age, Continuous | 62.5 year STANDARD_DEVIATION 12.2 | 59.3 year STANDARD_DEVIATION 13.2 | 60.9 year STANDARD_DEVIATION 12.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 31 Participants | 63 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Plasma Lactate Level | 1.1 mmol/L STANDARD_DEVIATION 0.5 | 1.0 mmol/L STANDARD_DEVIATION 0.4 | 1.0 mmol/L STANDARD_DEVIATION 0.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 32 Participants | 31 Participants | 63 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 32 participants | 31 participants | 63 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 22 Participants | 21 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 32 | 0 / 31 |
| other Total, other adverse events | 0 / 32 | 0 / 31 |
| serious Total, serious adverse events | 2 / 32 | 2 / 31 |
Outcome results
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
Time frame: After Initiation of NTG infusion During Rewarming
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-dose NTG | Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion | 6 Participants |
| Low-dose NTG | Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion | 0 Participants |
p-value: <0.001Fisher Exact
Primary
Plasma Glucose Level, After Protamine Administration
Plasma Glucose Level, mg/dL, After Cessation of CPB and Protamine Administration
Time frame: After Protamine Administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Plasma Glucose Level, After Protamine Administration | 196.9 mg/dL | Standard Deviation 53.8 |
| Low-dose NTG | Plasma Glucose Level, After Protamine Administration | 205.7 mg/dL | Standard Deviation 41.1 |
p-value: 0.478t-test, 2 sided
Primary
Plasma Glucose Level, Before Incision
Plasma Glucose Level, mg/dL, Before Incision
Time frame: Before Incision
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Plasma Glucose Level, Before Incision | 139.4 mg/dL | Standard Deviation 47.4 |
| Low-dose NTG | Plasma Glucose Level, Before Incision | 124.2 mg/dL | Standard Deviation 32 |
p-value: 0.144t-test, 2 sided
Primary
Plasma Glucose Level, Before Start of CPB
Plasma Glucose Level, mg/dL, Before Start of CPB
Time frame: Before Start of CPB
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Plasma Glucose Level, Before Start of CPB | 179.2 mg/dL | Standard Deviation 62.3 |
| Low-dose NTG | Plasma Glucose Level, Before Start of CPB | 165.7 mg/dL | Standard Deviation 46.2 |
p-value: 0.338t-test, 2 sided
Primary
Plasma Glucose Level, Release of Aortic Clamp
Plasma Glucose Level, mg/dL, Release of Aortic Clamp
Time frame: Release of Aortic Clamp
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Plasma Glucose Level, Release of Aortic Clamp | 174.5 mg/dL | Standard Deviation 49.5 |
| Low-dose NTG | Plasma Glucose Level, Release of Aortic Clamp | 165.0 mg/dL | Standard Deviation 29.3 |
p-value: 0.356t-test, 2 sided
Primary
Plasma Glucose Level, Upon Arrival at ICU
Plasma Glucose Level, mg/dL, Upon Arrival at ICU
Time frame: Upon Arrival at ICU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Plasma Glucose Level, Upon Arrival at ICU | 206.4 mg/dL | Standard Deviation 55.7 |
| Low-dose NTG | Plasma Glucose Level, Upon Arrival at ICU | 214.8 mg/dL | Standard Deviation 46.3 |
p-value: 0.515t-test, 2 sided
Primary
Plasma Lactate Level, After Protamine Administration
Plasma Lactate Level, mmol/L, After Cessation of CPB and Protamine Administration
Time frame: After Protamine Administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Plasma Lactate Level, After Protamine Administration | 3.3 mmol/L | Standard Deviation 1.2 |
| Low-dose NTG | Plasma Lactate Level, After Protamine Administration | 3.0 mmol/L | Standard Deviation 1.1 |
p-value: 0.32t-test, 2 sided
Primary
Plasma Lactate Level, Before Incision
Plasma Lactate Level, mmol/L, Before Incision
Time frame: Before Incision
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Plasma Lactate Level, Before Incision | 1.1 mmol/L | Standard Deviation 0.5 |
| Low-dose NTG | Plasma Lactate Level, Before Incision | 1.0 mmol/L | Standard Deviation 0.4 |
p-value: 0.618t-test, 2 sided
Primary
Plasma Lactate Level, Before Start of CPB
Plasma Lactate Level, mmol/L, Before Start of CPB
Time frame: Before Start of CPB
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Plasma Lactate Level, Before Start of CPB | 1.4 mmol/L | Standard Deviation 0.7 |
| Low-dose NTG | Plasma Lactate Level, Before Start of CPB | 1.6 mmol/L | Standard Deviation 0.7 |
p-value: 0.41t-test, 2 sided
Primary
Plasma Lactate Level, Release of Aortic Clamp
Plasma Lactate Level, mmol/L, Release of Aortic Clamp
Time frame: Release of Aortic Clamp
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Plasma Lactate Level, Release of Aortic Clamp | 3.1 mmol/L | Standard Deviation 1.2 |
| Low-dose NTG | Plasma Lactate Level, Release of Aortic Clamp | 2.6 mmol/L | Standard Deviation 1 |
p-value: 0.088t-test, 2 sided
Primary
Plasma Lactate Level, Upon Arrival at ICU
Plasma Lactate Level, mmol/L, Upon Arrival at ICU
Time frame: Upon Arrival at ICU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Plasma Lactate Level, Upon Arrival at ICU | 3.4 mmol/L | Standard Deviation 1.6 |
| Low-dose NTG | Plasma Lactate Level, Upon Arrival at ICU | 3.2 mmol/L | Standard Deviation 1.5 |
p-value: 0.512t-test, 2 sided
Secondary
Activated Coagulation Time, After Protamine Administration
Activated Coagulation Time, sec, After Cessation of CPB and Protamine Administration
Time frame: After Protamine Administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Activated Coagulation Time, After Protamine Administration | 144.2 second | Standard Deviation 15.9 |
| Low-dose NTG | Activated Coagulation Time, After Protamine Administration | 138.2 second | Standard Deviation 15.3 |
p-value: 0.141t-test, 2 sided
Secondary
Activated Coagulation Time, Before Start of CPB
Activated Coagulation Time, sec, Before Start of CPB
Time frame: Before Start of CPB
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Activated Coagulation Time, Before Start of CPB | 158.9 second | Standard Deviation 19.8 |
| Low-dose NTG | Activated Coagulation Time, Before Start of CPB | 153.1 second | Standard Deviation 18.1 |
p-value: 0.227t-test, 2 sided
Secondary
Length of ICU Stay
Time from Arrival at ICU to Leaving ICU, day
Time frame: Arrival at ICU and Leaving ICU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Length of ICU Stay | 4.1 day | Standard Deviation 1.8 |
| Low-dose NTG | Length of ICU Stay | 4.0 day | Standard Deviation 2 |
p-value: 0.948t-test, 2 sided
Secondary
Post-op Dopamine Infusion
Infusion Rate of Dopamine, mcg/kg/min, Upon Arrival at ICU
Time frame: Upon Arrival at ICU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Post-op Dopamine Infusion | 3.7 mcg/kg/min | Standard Deviation 1.8 |
| Low-dose NTG | Post-op Dopamine Infusion | 4.7 mcg/kg/min | Standard Deviation 2 |
p-value: 0.046t-test, 2 sided
Secondary
Time to Extubation
Time from Arrival at ICU to Extubation, hour
Time frame: Arrival at ICU and Extubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Time to Extubation | 43.6 hour | Standard Deviation 33.7 |
| Low-dose NTG | Time to Extubation | 45.8 hour | Standard Deviation 34.8 |
p-value: 0.8t-test, 2 sided
Other Pre-specified
Cardiac Index, After Protamine Administration
Cardiac Index, L/min/m2, After Protamine Administration
Time frame: After Protamine Administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Cardiac Index, After Protamine Administration | 3.2 L/min/m2 | Standard Deviation 1 |
| Low-dose NTG | Cardiac Index, After Protamine Administration | 3.1 L/min/m2 | Standard Deviation 0.7 |
p-value: 0.672t-test, 2 sided
Other Pre-specified
Cardiac Index, Before Start of CPB
Cardiac Index, L/min/m2, Before Start of CPB
Time frame: Before Start of CPB
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Cardiac Index, Before Start of CPB | 3.0 L/min/m2 | Standard Deviation 1.3 |
| Low-dose NTG | Cardiac Index, Before Start of CPB | 2.8 L/min/m2 | Standard Deviation 1.1 |
p-value: 0.682t-test, 2 sided
Other Pre-specified
Cardiac Index, Cessation of CPB
Cardiac Index, L/min/m2, Cessation of CPB
Time frame: Cessation of CPB
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Cardiac Index, Cessation of CPB | 2.6 L/min/m2 | Standard Deviation 1 |
| Low-dose NTG | Cardiac Index, Cessation of CPB | 2.7 L/min/m2 | Standard Deviation 0.6 |
p-value: 0.928t-test, 2 sided
Other Pre-specified
Cardiac Index, Upon Arrival at ICU
Cardiac Index, L/min/m2, Upon Arrival at ICU
Time frame: Upon Arrival at ICU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Cardiac Index, Upon Arrival at ICU | 3.3 L/min/m2 | Standard Deviation 0.9 |
| Low-dose NTG | Cardiac Index, Upon Arrival at ICU | 3.3 L/min/m2 | Standard Deviation 1.3 |
p-value: 0.894t-test, 2 sided
Other Pre-specified
Cerebral Oximetry, After Protamine Administration, Left Forehead
Absolute Value of Cerebral Oximetry, %, After Protamine Administration, Left Forehead
Time frame: After Protamine Administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Cerebral Oximetry, After Protamine Administration, Left Forehead | 74.9 % of Cerebral Oximetry | Standard Deviation 4.3 |
| Low-dose NTG | Cerebral Oximetry, After Protamine Administration, Left Forehead | 72.1 % of Cerebral Oximetry | Standard Deviation 6.9 |
p-value: 0.077t-test, 2 sided
Other Pre-specified
Cerebral Oximetry, After Protamine Administration, Right Forehead
Absolute Value of Cerebral Oximetry, %, After Protamine Administration, Right Forehead
Time frame: After Protamine Administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Cerebral Oximetry, After Protamine Administration, Right Forehead | 75.0 % of Cerebral Oximetry | Standard Deviation 4.7 |
| Low-dose NTG | Cerebral Oximetry, After Protamine Administration, Right Forehead | 74.3 % of Cerebral Oximetry | Standard Deviation 7.3 |
p-value: 0.64t-test, 2 sided
Other Pre-specified
Cerebral Oximetry, Before Start of CPB, Left Forehead
Absolute Value of Cerebral Oximetry, %, Before Start of CPB, Left Forehead
Time frame: Before Start of CPB
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Cerebral Oximetry, Before Start of CPB, Left Forehead | 74.4 % of Cerebral Oximetry | Standard Deviation 4.8 |
| Low-dose NTG | Cerebral Oximetry, Before Start of CPB, Left Forehead | 76.8 % of Cerebral Oximetry | Standard Deviation 6.9 |
p-value: 0.135t-test, 2 sided
Other Pre-specified
Cerebral Oximetry, Before Start of CPB, Right Forehead
Absolute Value of Cerebral Oximetry, %, Before Start of CPB, Right Forehead
Time frame: Before Start of CPB
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Cerebral Oximetry, Before Start of CPB, Right Forehead | 74.9 % of Cerebral Oximetry | Standard Deviation 4.6 |
| Low-dose NTG | Cerebral Oximetry, Before Start of CPB, Right Forehead | 77.9 % of Cerebral Oximetry | Standard Deviation 6 |
p-value: 0.038t-test, 2 sided
Other Pre-specified
Cerebral Oximetry, Beginning Rewarming, Left Forehead
Absolute Value of Cerebral Oximetry, %, Beginning Rewarming, Left Forehead
Time frame: Beginning Rewarming
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Cerebral Oximetry, Beginning Rewarming, Left Forehead | 68.0 % of Cerebral Oximetry | Standard Deviation 5.7 |
| Low-dose NTG | Cerebral Oximetry, Beginning Rewarming, Left Forehead | 68.4 % of Cerebral Oximetry | Standard Deviation 7.8 |
p-value: 0.852t-test, 2 sided
Other Pre-specified
Cerebral Oximetry, Beginning Rewarming, Right Forehead
Absolute Value of Cerebral Oximetry, %, Beginning Rewarming, Right Forehead
Time frame: Beginning Rewarming
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Cerebral Oximetry, Beginning Rewarming, Right Forehead | 67.9 % of Cerebral Oximetry | Standard Deviation 7.2 |
| Low-dose NTG | Cerebral Oximetry, Beginning Rewarming, Right Forehead | 69.5 % of Cerebral Oximetry | Standard Deviation 8.3 |
p-value: 0.454t-test, 2 sided
Other Pre-specified
Cerebral Oximetry, Cessation of CPB, Left Forehead
Absolute Value of Cerebral Oximetry, %, Cessation of CPB, Left Forehead
Time frame: Cessation of CPB
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Cerebral Oximetry, Cessation of CPB, Left Forehead | 71.1 % of Cerebral Oximetry | Standard Deviation 4 |
| Low-dose NTG | Cerebral Oximetry, Cessation of CPB, Left Forehead | 69.8 % of Cerebral Oximetry | Standard Deviation 5.8 |
p-value: 0.318t-test, 2 sided
Other Pre-specified
Cerebral Oximetry, Cessation of CPB, Right Forehead
Absolute Value of Cerebral Oximetry, %, Cessation of CPB, Right Forehead
Time frame: Cessation of CPB
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Cerebral Oximetry, Cessation of CPB, Right Forehead | 71.4 % of Cerebral Oximetry | Standard Deviation 4.9 |
| Low-dose NTG | Cerebral Oximetry, Cessation of CPB, Right Forehead | 70.0 % of Cerebral Oximetry | Standard Deviation 6.6 |
p-value: 0.365t-test, 2 sided
Other Pre-specified
Cerebral Oximetry, Release of Aortic Clamp, Left Forehead
Absolute Value of Cerebral Oximetry, %, Release of Aortic Clamp, Left Forehead
Time frame: Release of Aortic Clamp
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Cerebral Oximetry, Release of Aortic Clamp, Left Forehead | 67.4 % of Cerebral Oximetry | Standard Deviation 5.6 |
| Low-dose NTG | Cerebral Oximetry, Release of Aortic Clamp, Left Forehead | 66.8 % of Cerebral Oximetry | Standard Deviation 5.8 |
p-value: 0.663t-test, 2 sided
Other Pre-specified
Cerebral Oximetry, Release of Aortic Clamp, Right Forehead
Absolute Value of Cerebral Oximetry, %, Release of Aortic Clamp, Right Forehead
Time frame: Release of Aortic Clamp
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-dose NTG | Cerebral Oximetry, Release of Aortic Clamp, Right Forehead | 68.2 % of Cerebral Oximetry | Standard Deviation 6.1 |
| Low-dose NTG | Cerebral Oximetry, Release of Aortic Clamp, Right Forehead | 67.9 % of Cerebral Oximetry | Standard Deviation 6.7 |
p-value: 0.872t-test, 2 sided