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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00942786
Recruitment Status : Completed
First Posted : July 21, 2009
Results First Posted : June 29, 2015
Last Update Posted : June 29, 2015
Information provided by (Responsible Party):
Medical University of Graz

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

Condition or disease

Detailed Description:
The purpose of the study is to measure levels of brain natriuretic peptides before and after urgent non-cardiac surgery and to evaluate their predictive value for adverse long-term outcome.

Study Type : Observational
Actual Enrollment : 297 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study to Evaluate the Predictive Value of Brain Natriuretic Peptides for Adverse Long-term Cardiac Outcome
Study Start Date : February 2008
Actual Primary Completion Date : January 2014
Actual Study Completion Date : February 2014

No treatment
Consecutive patients undergoing emergency surgery

Primary Outcome Measures :
  1. Occurence of Adverse Cardiac Events [ Time Frame: 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.

Other Outcome Measures:
  1. NT-ProBNP Preoperative [ Time Frame: 0-24 hours before induction of anesthesia ]
    NT-ProBNP was measured 0-24 hours before induction of anesthesia

  2. Association Between Preoperative NT-ProBNP and Occurence of Adverse Cardiac Events [ Time Frame: 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

Biospecimen Retention:   Samples Without DNA
one vial of serum per patient is retained

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients undergoing emergency non-cardiac surgery

Inclusion criteria:

  • Emergency surgery:

    1. Vascular
    2. Intra-abdominal
    3. Orthopedic

      Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00942786

Department of Anesthesia and Intensive Care Medicine
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Principal Investigator: Elisabeth Mahla, M.D. Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz

Responsible Party: Medical University of Graz Identifier: NCT00942786     History of Changes
Other Study ID Numbers: 19-077 ex 07/08
First Posted: July 21, 2009    Key Record Dates
Results First Posted: June 29, 2015
Last Update Posted: June 29, 2015
Last Verified: June 2015

Keywords provided by Medical University of Graz:
natriuretic peptides
emergency non-cardiac surgery