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

Trauma Clinical Trial

— POCCET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02691650
• Other study ID #: Burns and Trauma POC ChE Study
• Status: Completed
• Start date: February 2016
• Est. completion date: October 2018

Study information

• Verified date: April 2019
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: October 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Multiple Trauma
• Trauma

Locations

Country	Name	City	State
Germany	Department of Anaesthesia, Intensive Care Medicine and Pain Therapy, BG Trauma Center Ludwigshafen	Ludwigshafen	Rheinland Pfalz

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Heidelberg	BG Trauma Center Ludwigshafen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	after completed patient recruitment, 1 year