Trial Outcomes & Findings for Nitroglycerin Infusion During Cardiac Surgery (NCT NCT01901419)

Results Overview

Plasma Lactate Level, mmol/L, Before Incision

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

Before Incision

Results posted on

2020-11-24

Participant Flow

elective cardiac surgery

Participant milestones

Participant milestones
Measure	High-dose NTG Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Overall Study STARTED	40	40
Overall Study COMPLETED	32	31
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Reasons for withdrawal
Measure	High-dose NTG Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Overall Study Protocol Violation	2	6
Overall Study unavailable researchers	6	3

Baseline Characteristics

Nitroglycerin Infusion During Cardiac Surgery

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Before Incision

Plasma Lactate Level, mmol/L, Before Incision

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Plasma Lactate Level, Before Incision	1.1 mmol/L Standard Deviation 0.5	1.0 mmol/L Standard Deviation 0.4

PRIMARY outcome

Timeframe: Before Start of CPB

Plasma Lactate Level, mmol/L, Before Start of CPB

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Plasma Lactate Level, Before Start of CPB	1.4 mmol/L Standard Deviation 0.7	1.6 mmol/L Standard Deviation 0.7

PRIMARY outcome

Timeframe: Release of Aortic Clamp

Plasma Lactate Level, mmol/L, Release of Aortic Clamp

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Plasma Lactate Level, Release of Aortic Clamp	3.1 mmol/L Standard Deviation 1.2	2.6 mmol/L Standard Deviation 1.0

PRIMARY outcome

Timeframe: After Protamine Administration

Plasma Lactate Level, mmol/L, After Cessation of CPB and Protamine Administration

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Plasma Lactate Level, After Protamine Administration	3.3 mmol/L Standard Deviation 1.2	3.0 mmol/L Standard Deviation 1.1

PRIMARY outcome

Timeframe: Upon Arrival at ICU

Plasma Lactate Level, mmol/L, Upon Arrival at ICU

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Plasma Lactate Level, Upon Arrival at ICU	3.4 mmol/L Standard Deviation 1.6	3.2 mmol/L Standard Deviation 1.5

PRIMARY outcome

Timeframe: Before Incision

Plasma Glucose Level, mg/dL, Before Incision

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Plasma Glucose Level, Before Incision	139.4 mg/dL Standard Deviation 47.4	124.2 mg/dL Standard Deviation 32.0

PRIMARY outcome

Timeframe: Before Start of CPB

Plasma Glucose Level, mg/dL, Before Start of CPB

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Plasma Glucose Level, Before Start of CPB	179.2 mg/dL Standard Deviation 62.3	165.7 mg/dL Standard Deviation 46.2

PRIMARY outcome

Timeframe: Release of Aortic Clamp

Plasma Glucose Level, mg/dL, Release of Aortic Clamp

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Plasma Glucose Level, Release of Aortic Clamp	174.5 mg/dL Standard Deviation 49.5	165.0 mg/dL Standard Deviation 29.3

PRIMARY outcome

Timeframe: After Protamine Administration

Plasma Glucose Level, mg/dL, After Cessation of CPB and Protamine Administration

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Plasma Glucose Level, After Protamine Administration	196.9 mg/dL Standard Deviation 53.8	205.7 mg/dL Standard Deviation 41.1

PRIMARY outcome

Timeframe: Upon Arrival at ICU

Plasma Glucose Level, mg/dL, Upon Arrival at ICU

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Plasma Glucose Level, Upon Arrival at ICU	206.4 mg/dL Standard Deviation 55.7	214.8 mg/dL Standard Deviation 46.3

PRIMARY outcome

Timeframe: After Initiation of NTG infusion During Rewarming

Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion During Rewarming of Cardiopulmonary Bypass

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion	6 Participants	0 Participants

SECONDARY outcome

Timeframe: Before Start of CPB

Activated Coagulation Time, sec, Before Start of CPB

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Activated Coagulation Time, Before Start of CPB	158.9 second Standard Deviation 19.8	153.1 second Standard Deviation 18.1

SECONDARY outcome

Timeframe: After Protamine Administration

Activated Coagulation Time, sec, After Cessation of CPB and Protamine Administration

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Activated Coagulation Time, After Protamine Administration	144.2 second Standard Deviation 15.9	138.2 second Standard Deviation 15.3

SECONDARY outcome

Timeframe: Upon Arrival at ICU

Infusion Rate of Dopamine, mcg/kg/min, Upon Arrival at ICU

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Post-op Dopamine Infusion	3.7 mcg/kg/min Standard Deviation 1.8	4.7 mcg/kg/min Standard Deviation 2.0

SECONDARY outcome

Timeframe: Arrival at ICU and Extubation

Time from Arrival at ICU to Extubation, hour

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Time to Extubation	43.6 hour Standard Deviation 33.7	45.8 hour Standard Deviation 34.8

SECONDARY outcome

Timeframe: Arrival at ICU and Leaving ICU

Time from Arrival at ICU to Leaving ICU, day

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Length of ICU Stay	4.1 day Standard Deviation 1.8	4.0 day Standard Deviation 2.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Before Start of CPB

Cardiac Index, L/min/m2, Before Start of CPB

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Cardiac Index, Before Start of CPB	3.0 L/min/m2 Standard Deviation 1.3	2.8 L/min/m2 Standard Deviation 1.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Cessation of CPB

Cardiac Index, L/min/m2, Cessation of CPB

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Cardiac Index, Cessation of CPB	2.6 L/min/m2 Standard Deviation 1.0	2.7 L/min/m2 Standard Deviation 0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: After Protamine Administration

Cardiac Index, L/min/m2, After Protamine Administration

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Cardiac Index, After Protamine Administration	3.2 L/min/m2 Standard Deviation 1.0	3.1 L/min/m2 Standard Deviation 0.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Upon Arrival at ICU

Cardiac Index, L/min/m2, Upon Arrival at ICU

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Cardiac Index, Upon Arrival at ICU	3.3 L/min/m2 Standard Deviation 0.9	3.3 L/min/m2 Standard Deviation 1.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Before Start of CPB

Absolute Value of Cerebral Oximetry, %, Before Start of CPB, Left Forehead

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Cerebral Oximetry, Before Start of CPB, Left Forehead	74.4 % of Cerebral Oximetry Standard Deviation 4.8	76.8 % of Cerebral Oximetry Standard Deviation 6.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Before Start of CPB

Absolute Value of Cerebral Oximetry, %, Before Start of CPB, Right Forehead

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Cerebral Oximetry, Before Start of CPB, Right Forehead	74.9 % of Cerebral Oximetry Standard Deviation 4.6	77.9 % of Cerebral Oximetry Standard Deviation 6.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Beginning Rewarming

Absolute Value of Cerebral Oximetry, %, Beginning Rewarming, Left Forehead

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Cerebral Oximetry, Beginning Rewarming, Left Forehead	68.0 % of Cerebral Oximetry Standard Deviation 5.7	68.4 % of Cerebral Oximetry Standard Deviation 7.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Beginning Rewarming

Absolute Value of Cerebral Oximetry, %, Beginning Rewarming, Right Forehead

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Cerebral Oximetry, Beginning Rewarming, Right Forehead	67.9 % of Cerebral Oximetry Standard Deviation 7.2	69.5 % of Cerebral Oximetry Standard Deviation 8.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Release of Aortic Clamp

Absolute Value of Cerebral Oximetry, %, Release of Aortic Clamp, Left Forehead

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Cerebral Oximetry, Release of Aortic Clamp, Left Forehead	67.4 % of Cerebral Oximetry Standard Deviation 5.6	66.8 % of Cerebral Oximetry Standard Deviation 5.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Release of Aortic Clamp

Absolute Value of Cerebral Oximetry, %, Release of Aortic Clamp, Right Forehead

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Cerebral Oximetry, Release of Aortic Clamp, Right Forehead	68.2 % of Cerebral Oximetry Standard Deviation 6.1	67.9 % of Cerebral Oximetry Standard Deviation 6.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Cessation of CPB

Absolute Value of Cerebral Oximetry, %, Cessation of CPB, Left Forehead

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Cerebral Oximetry, Cessation of CPB, Left Forehead	71.1 % of Cerebral Oximetry Standard Deviation 4.0	69.8 % of Cerebral Oximetry Standard Deviation 5.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Cessation of CPB

Absolute Value of Cerebral Oximetry, %, Cessation of CPB, Right Forehead

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Cerebral Oximetry, Cessation of CPB, Right Forehead	71.4 % of Cerebral Oximetry Standard Deviation 4.9	70.0 % of Cerebral Oximetry Standard Deviation 6.6

OTHER_PRE_SPECIFIED outcome

Timeframe: After Protamine Administration

Absolute Value of Cerebral Oximetry, %, After Protamine Administration, Left Forehead

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Cerebral Oximetry, After Protamine Administration, Left Forehead	74.9 % of Cerebral Oximetry Standard Deviation 4.3	72.1 % of Cerebral Oximetry Standard Deviation 6.9

OTHER_PRE_SPECIFIED outcome

Timeframe: After Protamine Administration

Absolute Value of Cerebral Oximetry, %, After Protamine Administration, Right Forehead

Outcome measures

Outcome measures
Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Cerebral Oximetry, After Protamine Administration, Right Forehead	75.0 % of Cerebral Oximetry Standard Deviation 4.7	74.3 % of Cerebral Oximetry Standard Deviation 7.3

Adverse Events

High-dose NTG

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Low-dose NTG

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	High-dose NTG n=32 participants at risk Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 participants at risk Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Surgical and medical procedures Re-sternotomy for bleeding	3.1% 1/32 • Number of events 1 • 30-day mortality and complications. Re-sternotomy for bleeding; Mediastinitis with septic shock; Pneumonia; Massive hemothorax	0.00% 0/31 • 30-day mortality and complications. Re-sternotomy for bleeding; Mediastinitis with septic shock; Pneumonia; Massive hemothorax
Infections and infestations Mediastinitis with septic shock	3.1% 1/32 • Number of events 1 • 30-day mortality and complications. Re-sternotomy for bleeding; Mediastinitis with septic shock; Pneumonia; Massive hemothorax	0.00% 0/31 • 30-day mortality and complications. Re-sternotomy for bleeding; Mediastinitis with septic shock; Pneumonia; Massive hemothorax
Infections and infestations Pneumonia	0.00% 0/32 • 30-day mortality and complications. Re-sternotomy for bleeding; Mediastinitis with septic shock; Pneumonia; Massive hemothorax	3.2% 1/31 • Number of events 1 • 30-day mortality and complications. Re-sternotomy for bleeding; Mediastinitis with septic shock; Pneumonia; Massive hemothorax
Surgical and medical procedures Massive hemothorax	0.00% 0/32 • 30-day mortality and complications. Re-sternotomy for bleeding; Mediastinitis with septic shock; Pneumonia; Massive hemothorax	3.2% 1/31 • Number of events 1 • 30-day mortality and complications. Re-sternotomy for bleeding; Mediastinitis with septic shock; Pneumonia; Massive hemothorax

Other adverse events

Adverse event data not reported

Additional Information

Dr. Tso-Chou Lin

Department of Anesthesiology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan

Phone: +886-2-87927128

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	High-dose NTG n=32 Participants Nitroglycerin infusion 1-5 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Low-dose NTG n=31 Participants Nitroglycerin infusion 0-0.1 mcg/kg/min Nitroglycerin infusion: Nitroglycerin infusion during rewarming	Total n=63 Participants Total of all reporting groups
Age, Continuous	62.5 year STANDARD_DEVIATION 12.2 • n=5 Participants	59.3 year STANDARD_DEVIATION 13.2 • n=7 Participants	60.9 year STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Taiwan	32 participants n=5 Participants	31 participants n=7 Participants	63 participants n=5 Participants
Plasma Lactate Level	1.1 mmol/L STANDARD_DEVIATION 0.5 • n=5 Participants	1.0 mmol/L STANDARD_DEVIATION 0.4 • n=7 Participants	1.0 mmol/L STANDARD_DEVIATION 0.5 • n=5 Participants