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

April 15, 2019 updated by: Aleksandar Zivkovic, University Hospital Heidelberg
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rheinland Pfalz
      • Ludwigshafen, Rheinland Pfalz, Germany, 67071
        • Department of Anaesthesia, Intensive Care Medicine and Pain Therapy, BG Trauma Center Ludwigshafen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the emergency unit of the trauma and burns center

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early diagnosis of the systemic inflammation by using the serum cholinesterase activity measurement
Time Frame: 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.
after completed patient recruitment, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation of the cholinesterase activity and the trauma/disease severity scores
Time Frame: 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).
after completed patient recruitment, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

February 16, 2016

First Submitted That Met QC Criteria

February 20, 2016

First Posted (Estimate)

February 25, 2016

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Burns and Trauma POC ChE Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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