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Completed

NCT Number: NCT02691650

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Ludwigshafen am Rhein, Rhineland-Palatinate, 67071, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

  • BG Trauma Center Ludwigshafen

Registry information

Acronym: POCCET

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 25, 2016
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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