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

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ClinicalTrials.gov Identifier: NCT02691650
Recruitment Status : Completed
First Posted : February 25, 2016
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
BG Trauma Center Ludwigshafen
Information provided by (Responsible Party):
Aleksandar Zivkovic, 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.

Condition or disease
Trauma Burns

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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 : February 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Biospecimen Retention:   Samples With DNA
A miniature amount (10 μl) of whole blood is needed for the serum cholinesterase activity analysis. This blood specimen will be taken from otherwise routine blood gas analysis collection, taken upon arrival into the emergency room, as a part of the standardized ICU diagnostic and therapeutic procedure. The serum cholinesterase activity analysis, therefore, doesn't require additional blood collection.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the emergency unit of the trauma and burns center
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691650


Locations
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Germany
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
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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

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Responsible Party: Aleksandar Zivkovic, Dr. med. Aleksandar Zivkovic, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT02691650     History of Changes
Other Study ID Numbers: Burns and Trauma POC ChE Study
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Aleksandar Zivkovic, University Hospital Heidelberg:
serum cholinesterase
plasma cholinesterase
pseudocholinesterase
systemic inflammation
SIRS
polytrauma

Additional relevant MeSH terms:
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Burns
Multiple Trauma
Wounds and Injuries