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

NCT ID: NCT02691650

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-10-31

Brief Summary

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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

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Conditions

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Trauma Burns

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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

* failure to adhere
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BG Trauma Center Ludwigshafen

OTHER

Sponsor Role collaborator

University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Aleksandar Zivkovic

Dr. med. Aleksandar Zivkovic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan Hofer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Heidelberg University Hospital

Stefan Kleinschmidt, Prof. Dr.

Role: STUDY_CHAIR

Department of Anaesthesia, Intensive Care Medicine and Pain Therapy, BG Trauma Centre Ludwigshafen, Ludwigshafen, Germany

Locations

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Department of Anaesthesia, Intensive Care Medicine and Pain Therapy, BG Trauma Center Ludwigshafen

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

Other Identifiers

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Burns and Trauma POC ChE Study

Identifier Type: -

Identifier Source: org_study_id

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