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NT-proBNP as a Tool for the Detection of Acute Pulmonary Artery Embolism (APE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claus-Martin Muth, University of Ulm
ClinicalTrials.gov Identifier:
NCT01633671
First received: June 28, 2012
Last updated: July 4, 2012
Last verified: July 2012
History of Changes
  Purpose

In patients with suspected APE (Acute Pulmonary Embolism) referred to the intensive care unit (ICU)after major surgery, serum NT-proBNP (N-terminal proBNP), Troponin-I and D-dimers were measured according to the standard hospital protocol. To definitively confirm or exclude APE, all patients underwent an angiographic CT-scan of the thorax.


Condition
Pulmonary Embolism
Pulmonary Embolism Without Mention of Acute Cor Pulmonale

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: NT-proBNP: a Useful Tool for the Detection of Acute Pulmonary Artery Embolism in Post-surgical Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Acute pulmonary embolism: CT-proof yes vs. no [ Time Frame: 1 hour after onset of clinical symptoms ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: November 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Suspected APE
Post-surgical patients with clinically suspected acute pulmonary embolism

Detailed Description:

In patients with suspected APE referred to the intensive care unit after major surgery, serum NT-proBNP, Troponin-I and D-dimers were measured according to the standard hospital protocol. Blood samples were obtained within one hour after the onset of clinical symptoms.

Definitive confirmation or exclusion of APE was performed with an angiographic CT-scan of the thorax.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients after major surgery referred to the anesthesiologic ICU due to suspected acute pulmonary embolism.

Criteria

Inclusion Criteria:

all patients referred to the ICU with suspected APE

Exclusion Criteria:

none

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633671

Locations
Germany
University of Ulm, Michelsberg anaesthesiologic ICU
Ulm, Baden-Wuerttemberg, Germany, 89075
Sponsors and Collaborators
University of Ulm
Investigators
Study Chair: Claus M Muth, MD Dept. of Anesthesiology, Div. of Emergency medicine, University hospital Ulm, 89075 Ulm, Germany
Principal Investigator: Bernd E Winkler, MD Dept. of Anesthesiology, University hospital Ulm, 89075 Ulm, Germany
  More Information

No publications provided

Responsible Party: Claus-Martin Muth, Claus-Martin Muth, MD, PhD - Head of the Department of Emergency Medicine, University of Ulm
ClinicalTrials.gov Identifier: NCT01633671     History of Changes
Other Study ID Numbers: ana-ulm-ntprobnp-288/11
Study First Received: June 28, 2012
Last Updated: July 4, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Ulm:
Misadventures to Patients During Surgical and Medical Care
Pulmonary Embolism Without Acute Cor Pulmonale
Pulmonary Embolism Without Mention of Acute Cor Pulmonale

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Pulmonary Heart Disease
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Diseases

ClinicalTrials.gov processed this record on May 22, 2013