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

June 9, 2015 updated by: Medical University of Graz

Prospective Study to Evaluate the Predictive Value of Brain Natriuretic Peptides for Adverse Long-term Cardiac Outcome

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

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

297

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Graz, Austria, 8036
        • Department of Anesthesia and Intensive Care Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients undergoing emergency non-cardiac surgery

Description

Inclusion criteria:

  • Emergency surgery:

    1. Vascular
    2. Intra-abdominal
    3. Orthopedic

      Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
No treatment
Consecutive patients undergoing emergency surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
NT-ProBNP Preoperative
Time Frame: 0-24 hours before induction of anesthesia
NT-ProBNP was measured 0-24 hours before induction of anesthesia
0-24 hours before induction of anesthesia
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
postoperatively (index surgery) until a median follow-up of 34 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elisabeth Mahla, M.D., Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

July 18, 2009

First Submitted That Met QC Criteria

July 20, 2009

First Posted (Estimate)

July 21, 2009

Study Record Updates

Last Update Posted (Estimate)

June 29, 2015

Last Update Submitted That Met QC Criteria

June 9, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 19-077 ex 07/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgery

3
Subscribe