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

Sponsor

University Hospital Heidelberg (Other)

Overall Status

Completed

CT.gov ID

NCT02691650

Collaborator

BG Trauma Center Ludwigshafen (Other)

Enrollment

Location

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma Burns

Study Design

Study Type:

Observational

Actual Enrollment :

85 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
polytrauma patients Patients with severe traumatic injury, admitted to the emergency unit. Serum cholinesterase activity measurement using 10 µl whole blood, otherwise obtained through routine blood gas analysis upon arrival to the hospital.
burns patients Patients with burns trauma, admitted to the emergency unit. Serum cholinesterase activity measurement using 10 µl whole blood, otherwise obtained through routine blood gas analysis upon arrival to the hospital.

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anaesthesia, Intensive Care Medicine and Pain Therapy, BG Trauma Center Ludwigshafen	Ludwigshafen	Rheinland Pfalz	Germany	67071

Sponsors and Collaborators

University Hospital Heidelberg
BG Trauma Center Ludwigshafen

Investigators

Principal Investigator: Stefan Hofer, Prof. Dr., Department of Anesthesiology, Heidelberg University Hospital
Study Chair: Stefan Kleinschmidt, Prof. Dr., Department of Anaesthesia, Intensive Care Medicine and Pain Therapy, BG Trauma Centre Ludwigshafen, Ludwigshafen, Germany