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

NCT00942786 | Completed Results DMC

• 1 other identifier: 19-077 ex 07/08
• Study Type: observational
• Target: 297
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that the level of perioperative natriuretic peptides is associated with in-hospital and long term major adverse cardiac events.

Conditions

Surgery

Keywords

natriuretic peptides; emergency non-cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Occurence of Adverse Cardiac Events

  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.

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

Other Outcomes (2)

• NT-ProBNP Preoperative

  0-24 hours before induction of anesthesia

• Association Between Preoperative NT-ProBNP and Occurence of Adverse Cardiac Events

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

Study Arms (1)

No treatment

Consecutive patients undergoing emergency surgery

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients undergoing emergency non-cardiac surgery

You may qualify if:

• Emergency surgery:
• Vascular
• Intra-abdominal
• Orthopedic

You may not qualify if:

• Patients unable to provide informed consent
• Thoracic surgery
• Trauma surgery

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Anesthesia and Intensive Care Medicine

Graz, 8036, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

one vial of serum per patient is retained

Results Point of Contact

• Title: Elisabeth Mahla, MD
• Organization: Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Austria

elisabeth.mahla@medunigraz.at

++43316385

Study Officials

• Elisabeth Mahla, M.D.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2009
• First Posted: July 21, 2009
• Study Start: February 1, 2008
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 29, 2015
• Results First Posted: June 29, 2015

Record last verified: 2015-06

Locations

AU (1)