Perioperative Cardiac Troponin Levels in Healthy Adults

Extremity Orthopedic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02394288
• Other study ID #: 1579/2014
• Status: Recruiting
• Phase: N/A
• First received: March 13, 2015
• Last updated: October 24, 2015
• Start date: March 2015
• Est. completion date: January 2016

Study information

• Verified date: October 2015
• Source: Medical University of Vienna
• Contact: Andreas Duma, MD, MSc
• Phone: +43140400
• Email: andreas.duma[@]medunwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Extremity Orthopedic Surgery

Intervention

Procedure:
• Extremity orthopedic or trauma surgery
hip, leg, shoulder, arm

Locations

Country	Name	City	State
Austria	Division of General Anaesthesia and Intensive Care Medicine, Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Washington University School of Medicine

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative change of high-sensitivity cardiac troponin plasma level	3 samples: Preoperative,; POD 0, and; POD 1	24 hours preoperatively to postoperative day (POD) 1	No
Secondary	Peak high-sensitivity cardiac troponin plasma level	3 samples: Preoperative,; POD 0, and; POD 1	24 hours preoperatively to POD 1	No
Secondary	Incidence rate of high-sensitivity cardiac troponin plasma level elevation	3 samples: Preoperative,; POD 0, and; POD 1	24 hours preoperatively to POD 1	No