Trial Outcomes & Findings for Glutamate for Metabolic Intervention in Coronary Surgery (NCT NCT00489827)

NCT ID: NCT00489827

Last Updated: 2024-05-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 865 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2024-05-22

Participant Flow

4 patients, 2 in each group were excluded because of intraoperative exclusion criteria

Participant milestones

Measure	Intravenous Glutamate Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.	Saline Infusion Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Overall Study STARTED	430	435
Overall Study COMPLETED	428	433
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Intravenous Glutamate Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.	Saline Infusion Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Overall Study Intraoperative exclusion criteria	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intravenous Glutamate n=428 Participants Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.	Saline Infusion n=433 Participants Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.	Total n=861 Participants Total of all reporting groups
Age, Continuous	68 years STANDARD_DEVIATION 9 • n=428 Participants	68 years STANDARD_DEVIATION 9 • n=433 Participants	68 years STANDARD_DEVIATION 9 • n=861 Participants
Sex: Female, Male Female	75 Participants n=428 Participants	82 Participants n=433 Participants	157 Participants n=861 Participants
Sex: Female, Male Male	353 Participants n=428 Participants	351 Participants n=433 Participants	704 Participants n=861 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Sweden	428 participants n=428 Participants	433 participants n=433 Participants	861 participants n=861 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Measure	Intravenous Glutamate n=428 Participants Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.	Saline Infusion n=433 Participants Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Number of Participants With Perioperative Myocardial Infarction, Postoperative Heart Failure or Postoperative Mortality	31 Participants	25 Participants

SECONDARY outcome

Timeframe: perioperative

p-CK-MB postoperative day 1, p-troponin-T postoperative day 3

Outcome measures

Measure	Intravenous Glutamate n=411 Participants Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.	Saline Infusion n=427 Participants Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Degree of Perioperative Myocardial Injury CK-MB day 1	14 µg/L Interval 10.0 to 23.0	14 µg/L Interval 10.0 to 23.0
Degree of Perioperative Myocardial Injury Troponin-T day 3	0.27 µg/L Interval 0.16 to 0.57	0.24 µg/L Interval 0.13 to 0.52

SECONDARY outcome

Timeframe: Until arrival to ICU

Mixed venous oxygen saturation (SvO2) measured at weaning from cardiopulmonary bypass and on arrival to ICU

Outcome measures

Measure	Intravenous Glutamate n=416 Participants Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.	Saline Infusion n=421 Participants Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Postoperative Hemodynamic State SvO2 on arrival to ICU	65.0 percentage of saturated hemoglobin Standard Deviation 7.0	64.9 percentage of saturated hemoglobin Standard Deviation 6.9
Postoperative Hemodynamic State SvO2 at weaning from CPB	72.0 percentage of saturated hemoglobin Standard Deviation 7.6	72.2 percentage of saturated hemoglobin Standard Deviation 7.3

SECONDARY outcome

Timeframe: End of surgery

Population: Moderately or severely reduced LVEF (\<0.40)

Hemodynamic instability despite inotropes or need for IABP at the end of surgery in patients with severely reduced left ventricular ejection fraction (LVEF<0.40)

Outcome measures

Measure	Intravenous Glutamate n=71 Participants Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.	Saline Infusion n=75 Participants Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Postoperative Hemodynamic State in Patients With Severely Reduced Left Ventricular Ejection Fraction (LVEF<0.40)	1 Participants	5 Participants

SECONDARY outcome

Timeframe: 30 days

maximum p-creatinine value recorded postoperatively < 30 days

Outcome measures

Measure	Intravenous Glutamate n=428 Participants Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.	Saline Infusion n=433 Participants Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Postoperative Renal Function	106 µmol/L Standard Deviation 50	106 µmol/L Standard Deviation 50

SECONDARY outcome

Timeframe: 24 hours

Incidence of Postoperative stroke < 24 hours of surgery verifed by CT-scan

Outcome measures

Measure	Intravenous Glutamate n=428 Participants Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.	Saline Infusion n=433 Participants Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Number of Participants With Postoperative Stroke < 24 Hours	4 Participants	6 Participants

SECONDARY outcome

Timeframe: ICU stay

ICU duration of stay (hours)

Outcome measures

Measure	Intravenous Glutamate n=428 Participants Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.	Saline Infusion n=433 Participants Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
ICU Stay	21 hours Interval 17.0 to 23.0	21 hours Interval 17.0 to 23.0

SECONDARY outcome

Timeframe: Hospital stay

Number of patients with atrial fibrillation recorded postoperatively

Outcome measures

Measure	Intravenous Glutamate n=428 Participants Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.	Saline Infusion n=433 Participants Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Atrial Fibrillation	147 Participants	152 Participants

SECONDARY outcome

Timeframe: 30 days

Population: CCS class IV patients

Severe circulatory failure according to prespecified criteria as judged by a blinded endpoints committee in CCS class IV patients

Outcome measures

Measure	Intravenous Glutamate n=225 Participants Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.	Saline Infusion n=233 Participants Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Severe Circulatory Failure in CCS Class IV Patients	3 Participants	16 Participants

SECONDARY outcome

Timeframe: 10 year - survival (crude)

Population: Two patients were lost to follow-up, one in each group. One patient had moved abroad, the other one for unknown reason.

10-year survival - related to intervention. Last follow-up August 3, 2022. Follow-up time ranged from 12.7-16.8 years.

Outcome measures

Measure	Intravenous Glutamate n=427 Participants Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.	Saline Infusion n=432 Participants Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
10-year Survival	301 Participants	301 Participants

SECONDARY outcome

Timeframe: 30 days

Postoperative mortality within 30 days of surgery

Outcome measures

Measure	Intravenous Glutamate n=428 Participants Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.	Saline Infusion n=433 Participants Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Postoperative Mortality	4 Participants	5 Participants

Adverse Events

Intravenous Glutamate

Serious events: 54 serious events

Other events: 164 other events

Deaths: 126 deaths

Saline Infusion

Serious events: 59 serious events

Other events: 165 other events

Deaths: 131 deaths

Serious adverse events

Measure	Intravenous Glutamate n=428 participants at risk Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.	Saline Infusion n=433 participants at risk Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Nervous system disorders Stroke < 24 hours	0.93% 4/428 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital	1.4% 6/433 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital
Cardiac disorders Severe circulatory failure	2.3% 10/428 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital	4.2% 18/433 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital
Cardiac disorders Perioperative myocardial infarction	2.6% 11/428 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital	1.4% 6/433 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital
Cardiac disorders Cardiac mortality	0.23% 1/428 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital	0.92% 4/433 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital
Renal and urinary disorders Postoperative dialysis	0.47% 2/428 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital	1.4% 6/433 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital
Blood and lymphatic system disorders Reoperation for bleeding	5.1% 22/428 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital	4.8% 21/433 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital
Infections and infestations Infection	0.93% 4/428 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital	1.8% 8/433 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital
Surgical and medical procedures Postoperative mortality	0.93% 4/428 • Number of events 4 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital	1.2% 5/433 • Number of events 5 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital

Other adverse events

Measure	Intravenous Glutamate n=428 participants at risk Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.	Saline Infusion n=433 participants at risk Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Gastrointestinal disorders Postoperative nausea	32.5% 139/428 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital	26.3% 114/433 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital
Cardiac disorders Postoperative atrial fibrillation	34.3% 147/428 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital	35.1% 152/433 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital
Infections and infestations Infection	7.7% 33/428 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital	6.2% 27/433 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital
Respiratory, thoracic and mediastinal disorders Respiratory	9.1% 39/428 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital	10.4% 45/433 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital
Skin and subcutaneous tissue disorders Skin reaction	0.70% 3/428 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital	1.6% 7/433 • All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital

Additional Information

Rolf Svedjeholm

Dept Cardiothoracic Surgery, Linköping University Hospital, SE58185 Linköping, Sweden

Phone: +46101034825

Email: rolf.svedjeholm@regionostergotland.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place