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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00942786
First received: July 18, 2009
Last updated: June 9, 2015
Last verified: June 2015
Results First Received: January 26, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Surgery

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
No Treatment Consecutive patients undergoing emergency surgery

Participant Flow:   Overall Study
    No Treatment  
STARTED     297  
COMPLETED     297 [1]
NOT COMPLETED     0  
[1] date of last follow-up



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
One Arm consecutive patients presenting for emergent non-cardiac surgery

Baseline Measures
    One Arm  
Number of Participants  
[units: participants]
  297  
Age  
[units: years]
Mean (Full Range)
  74   (51 to 103)  
Gender  
[units: participants]
 
Female     180  
Male     117  



  Outcome Measures
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1.  Primary:   Occurence of Adverse Cardiac Events   [ Time Frame: postoperatively (index surgery) until a median follow-up of 34 months ]

2.  Other Pre-specified:   NT-ProBNP Preoperative   [ Time Frame: 0-24 hours before induction of anesthesia ]

3.  Other Pre-specified:   Association Between Preoperative NT-ProBNP and Occurence of Adverse Cardiac Events   [ Time Frame: postoperatively (index surgery) until a median follow-up of 34 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Elisabeth Mahla, MD
Organization: Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Austria
phone: ++43316385 ext 13027
e-mail: elisabeth.mahla@medunigraz.at


No publications provided


Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT00942786     History of Changes
Other Study ID Numbers: 19-077 ex 07/08
Study First Received: July 18, 2009
Results First Received: January 26, 2015
Last Updated: June 9, 2015
Health Authority: Austria: Ethikkommission