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CompletedNCT02691650POCCETUpdated Apr 16, 2019

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

An observational study in Trauma and Burns, sponsored by University Hospital Heidelberg. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-16.

Sponsored by University Hospital Heidelberg · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
85
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Trauma
  • Burns

Keywords

  • serum cholinesterase
  • plasma cholinesterase
  • pseudocholinesterase
  • systemic inflammation
  • SIRS
  • polytrauma
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In context

Burns

719 studies on the registry are indexed under Burns; 145 are open to participants now.

This study's enrollment of 85 is above the median of 55 across 135 observational studies indexed under Burns.

Browse Burns studies →

Lead sponsor

University Hospital Heidelberg is the lead sponsor of 175 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • not fulfilling the inclusion criteria
  • failure to adhere
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
85 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. Early diagnosis of the systemic inflammation by using the serum cholinesterase activity measurement

    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.

    Time frame: after completed patient recruitment, 1 year

Secondary outcomes

  1. correlation of the cholinesterase activity and the trauma/disease severity scores

    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).

    Time frame: after completed patient recruitment, 1 year

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Study locations

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

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02691650
Lead sponsor
University Hospital Heidelberg
Collaborators
BG Trauma Center Ludwigshafen
Responsible party
Aleksandar Zivkovic (Dr. med. Aleksandar Zivkovic, University Hospital Heidelberg) — Principal investigator
First posted
Feb 25, 2016
Start date
Feb 2016
Primary completion
Feb 2018
Completion
Oct 2018
Last update
Apr 16, 2019

Study contacts

Stefan Hofer, Prof. Dr.
principal investigator · Department of Anesthesiology, Heidelberg University Hospital
Stefan Kleinschmidt, Prof. Dr.
study chair · Department of Anaesthesia, Intensive Care Medicine and Pain Therapy, BG Trauma Centre Ludwigshafen, Ludwigshafen, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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