Trial Outcomes & Findings for Natriuretic Peptides - Predictors of In-hospital and Long-term Major Adverse Cardiac Events After Emergency Surgery? (NCT NCT00942786)

Results Overview

Occurence of major adverse cardiac events (composite of nonfatal myocardial infarction, acute heart failure or death). Non-fatal Myocardial infarction was defined as a typical increase and decrease of troponin together with evidence of myocardial ischemia with at least one of the following: symptoms of ischemia, ECG changes indicative of ischemia or new Q waves, or imaging evidence of new regional wall motion abnormality. Acute heart failure was defined as clinical signs and symptoms of heart failure with echocardiographic evidence of cardiac dysfunction and clinical response to treatment directed towards heart failure.

Recruitment status

COMPLETED

Target enrollment

297 participants

Primary outcome timeframe

postoperatively (index surgery) until a median follow-up of 34 months

Results posted on

2015-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	No Treatment Consecutive patients undergoing emergency surgery
Overall Study STARTED	297
Overall Study COMPLETED	297
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Natriuretic Peptides - Predictors of In-hospital and Long-term Major Adverse Cardiac Events After Emergency Surgery?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	One Arm n=297 Participants consecutive patients presenting for emergent non-cardiac surgery
Age, Continuous	74 years n=5 Participants
Sex: Female, Male Female	180 Participants n=5 Participants
Sex: Female, Male Male	117 Participants n=5 Participants

PRIMARY outcome

Timeframe: postoperatively (index surgery) until a median follow-up of 34 months

Occurence of major adverse cardiac events (composite of nonfatal myocardial infarction, acute heart failure or death). Non-fatal Myocardial infarction was defined as a typical increase and decrease of troponin together with evidence of myocardial ischemia with at least one of the following: symptoms of ischemia, ECG changes indicative of ischemia or new Q waves, or imaging evidence of new regional wall motion abnormality. Acute heart failure was defined as clinical signs and symptoms of heart failure with echocardiographic evidence of cardiac dysfunction and clinical response to treatment directed towards heart failure.

Outcome measures

Outcome measures
Measure	No Treatment n=297 Participants Consecutive patients undergoing emergency surgery	Patients Not Sustaining Adverse Events Subjects who did not reach the primary endpoint
Occurence of Adverse Cardiac Events	91 participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 0-24 hours before induction of anesthesia

Population: Consecutive patients undergoing emergent non-cardiac surgery

NT-ProBNP was measured 0-24 hours before induction of anesthesia

Outcome measures

Outcome measures
Measure	No Treatment n=297 Participants Consecutive patients undergoing emergency surgery	Patients Not Sustaining Adverse Events Subjects who did not reach the primary endpoint
NT-ProBNP Preoperative	491 pg/ml Interval 189.0 to 1670.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: postoperatively (index surgery) until a median follow-up of 34 months

Evaluation of the association between preoperative NT-ProBNP and occurence of adverse cardiac events

Outcome measures

Outcome measures
Measure	No Treatment n=91 Participants Consecutive patients undergoing emergency surgery	Patients Not Sustaining Adverse Events n=206 Participants Subjects who did not reach the primary endpoint
Association Between Preoperative NT-ProBNP and Occurence of Adverse Cardiac Events	1527 pg/ml Interval 544.0 to 3650.0	296 pg/ml Interval 119.0 to 873.0

Adverse Events

One Arm

Serious events: 91 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	One Arm n=297 participants at risk consecutive patients presenting for emergent non-cardiac surgery Patients were followed for occurence of major adverse cardiac events
Cardiac disorders Serious Adverse cardiac events	30.6% 91/297 • Number of events 91 • Median follow-up of 34 months

Other adverse events

Adverse event data not reported

Additional Information

Elisabeth Mahla, MD

Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Austria

Phone: ++43316385

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place