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

NCT02691650 | Completed

• 1 other identifier: Burns and Trauma POC ChE Study
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma; Burns

Keywords

serum cholinesterase; plasma cholinesterase; pseudocholinesterase; systemic inflammation; SIRS; polytrauma

Outcome Measures

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.

  after completed patient recruitment, 1 year

Secondary Outcomes (1)

• correlation of the cholinesterase activity and the trauma/disease severity scores

  after completed patient recruitment, 1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• signed written consent
• 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

You may not qualify if:

• failure to adhere

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• BG Trauma Center Ludwigshafen: collaborator

Study Sites (1)

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

Ludwigshafen am Rhein, Rhineland-Palatinate, 67071, Germany

Location

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.

MeSH Terms

Conditions

Wounds and Injuries; Burns; Butyrylcholinesterase deficiency; Multiple Trauma

Study Officials

• Stefan Hofer, Prof. Dr.

  Department of Anesthesiology, Heidelberg University Hospital

  PRINCIPAL INVESTIGATOR

• Stefan Kleinschmidt, Prof. Dr.

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Aleksandar Zivkovic

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 25, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: October 1, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)