Point of Care Testing of Cholinesterase Activity During Burn- and Polytrauma

Completed

• Conditions: Burns; Trauma

• Registration Number: NCT02691650
• Lead Sponsor: University Hospital Heidelberg

Brief Summary

Goal of this study is to measure serum cholinesterase activity in patients with traumatic and/or burns injury admitted to the emergency room by using point-of- care-test system (POCT). Serum cholinesterase activity, measured using POCT system, might play an important role in the early diagnosis and prediction of patient outcome in trauma-induced systemic inflammation.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-16
• Study First Submitted QC: 2016-02-20
• Study First Posted: 2016-02-25
• Primary Completion: 2018-02
• Study Completion: 2018-10
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• signed written consent
• 18 years and older
• severe trauma (ISS > 15)
• burns injury (2. degree more than 15% body surface or 3 degree more than 10% body surface)
• SIRS

Exclusion Criteria

• not fulfilling the inclusion criteria
• failure to adhere

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early diagnosis of the systemic inflammation by using the serum cholinesterase activity measurement	after completed patient recruitment, 1 year	By using Point-of-care measurement of serum cholinesterase activity (U/l) and by observing a change in the enzyme activity over time (reduction of serum cholinesterase activity within the first 6 hours after traumatic injury) would allow an additional tool in early diagnosis and treatment of systemic inflammation.

Secondary Outcome Measures

Name	Time	Method
correlation of the cholinesterase activity and the trauma/disease severity scores	after completed patient recruitment, 1 year	To evaluate the correlation of the serum cholinesterase activity change with the trauma severity, the obtained serum cholinesterase activities (U/l) will be compared to the trauma severity scores (ISS, %TBSA).

Trial Locations

Locations (1)

Department of Anaesthesia, Intensive Care Medicine and Pain Therapy, BG Trauma Center Ludwigshafen; 🇩🇪 Ludwigshafen, Rheinland Pfalz, Germany