Perioperative Cardiac Troponin Levels in Healthy Adults

March 18, 2016 updated by: Andreas Duma, Medical University of Vienna

Perioperative High-sensitivity Cardiac Troponin Levels in Healthy Adults Undergoing Elective Trauma Surgery

This study will determine the extent of high-sensitivity cardiac troponin (hs-cTn) release in patients without cardiac risk factors undergoing extremity orthopedic surgery. This study will provide important evidence on how to interpret postoperative cardiac troponin elevations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

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

  • Austria
      • Vienna, Austria, 1090
        • Division of General Anaesthesia and Intensive Care Medicine, Medical University of Vienna

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing extremity surgery without history of cardiovascular disease

Description

Inclusion Criteria:

  • Age 18-35 years
  • Extremity orthopedic or trauma surgery: leg, hip, arm, shoulder.
  • Planned overnight hospital admission
  • No cardiac risk factors (Lee's Revised Cardiac Risk Index Class 1)
  • American Society of Anesthesiologists (ASA) physical status I-II

Exclusion Criteria:

  • Any history or symptoms of cardiac disease
  • Kidney or liver disease
  • Recent or current trauma to the trunk or head
  • Persons with increased vulnerability (e.g. cognitive limitations, prisoners,…)
  • Pregnancy

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
Intervention / Treatment
Adults without cardiac disease
Extremity orthopedic or trauma surgery
Procedure: Extremity orthopedic or trauma surgery
hip, leg, shoulder, arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative change of high-sensitivity cardiac troponin plasma level
Time Frame: 24 hours preoperatively to postoperative day (POD) 1

3 samples:

  1. Preoperative,
  2. POD 0, and
  3. POD 1
24 hours preoperatively to postoperative day (POD) 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak high-sensitivity cardiac troponin plasma level
Time Frame: 24 hours preoperatively to POD 1

3 samples:

  1. Preoperative,
  2. POD 0, and
  3. POD 1
24 hours preoperatively to POD 1
Incidence rate of high-sensitivity cardiac troponin plasma level elevation
Time Frame: 24 hours preoperatively to POD 1

3 samples:

  1. Preoperative,
  2. POD 0, and
  3. POD 1
24 hours preoperatively to POD 1

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

Collaborators

Washington University School of Medicine

Investigators

  • Principal Investigator: Andreas Duma, MD, MSc, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 13, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 20, 2015

Study Record Updates

Last Update Posted (Estimate)

March 21, 2016

Last Update Submitted That Met QC Criteria

March 18, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1579/2014

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.

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