Perioperative Cardiac Troponin Levels in Healthy Adults

Completed

• Conditions: Extremity Orthopedic Surgery
• Interventions: Procedure: Extremity orthopedic or trauma surgery

• Registration Number: NCT02394288
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-13
• Study First Submitted QC: 2015-03-18
• Study First Posted: 2015-03-20
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-18
• Last Update Posted: 2016-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults without cardiac disease	Extremity orthopedic or trauma surgery	Extremity orthopedic or trauma surgery

Primary Outcome Measures

Name	Time	Method
Perioperative change of high-sensitivity cardiac troponin plasma level	24 hours preoperatively to postoperative day (POD) 1	3 samples: 1. Preoperative,; 2. POD 0, and; 3. POD 1

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Division of General Anaesthesia and Intensive Care Medicine, Medical University of Vienna; 🇦🇹 Vienna, Austria