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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00942786
• Other study ID #: 19-077 ex 07/08
• Status: Completed
• Phase: N/A
• First received: July 18, 2009
• Last updated: June 9, 2015
• Start date: February 2008
• Est. completion date: February 2014

Study information

• Verified date: June 2015
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion criteria:

• Emergency surgery:

1. Vascular

2. Intra-abdominal

3. Orthopedic

Exclusion Criteria:

• Patients unable to provide informed consent

• Thoracic surgery

• Trauma surgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Surgery

Locations

Country	Name	City	State
Austria	Department of Anesthesia and Intensive Care Medicine	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NT-ProBNP Preoperative	NT-ProBNP was measured 0-24 hours before induction of anesthesia	0-24 hours before induction of anesthesia	No
Other	Association Between Preoperative NT-ProBNP and Occurence of Adverse Cardiac Events	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	No
Primary	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	Yes