Feasibility of Lactate Level Evaluation in Prehospital Care in Trauma

Trauma, Multiple Clinical Trial

Official title:

Feasibility of Lactate Level Evaluation in Prehospital Care in Trauma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03115970
• Other study ID #: KAPIM-L
• Status: Not yet recruiting
• Phase: N/A
• First received: April 9, 2017
• Last updated: April 12, 2017
• Start date: May 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2017
• Source: Masaryk Hospital Usti nad Labem
• Contact: Marcela Bilska, Dr.
• Phone: +420723715208
• Email: marcela.bilska[@]kzcr.eu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Capillary or venous lactate level evaluation in prehospital care could be simple and beneficial tool for optimising prehospital care in patients with severe trauma.

Description:

Evaluation of blood lactate level and its trend are important morbidity and mortality predictive factors. In prehospital care, lactate level is more sensitive marker and have better prognostic value in severe trauma than basic vital signs. Worse outcome is associated with levels between 2 - 4 mmol/l. Measurement of lactate level in venous or capillary blood is quick and simple method with minimal risks and with no special needs for medical staff training. In spite of good availability of this method in the Czech Republic the method feasibility has never been analysed in patients with severe trauma.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient having / suspected to have severe trauma treated by cooperating Emergency Medical System organization

Exclusion Criteria:

• possible alterations of plasma lactate level in the time of trauma (seizure, malignity, use of beta-2 agonists, severe liver and/or kidney failure, ketoacidosis, intoxication)

Related Conditions & MeSH terms

• Hyperlactatemia
• Lactate Blood Increase
• Multiple Trauma
• Trauma, Multiple
• Wounds and Injuries

Intervention

Procedure:
• capillary and venous lactate level measurement
capillary and venous lactate level measurement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Masaryk Hospital Usti nad Labem

References & Publications (4)

Jansen TC, van Bommel J, Mulder PG, Rommes JH, Schieveld SJ, Bakker J. The prognostic value of blood lactate levels relative to that of vital signs in the pre-hospital setting: a pilot study. Crit Care. 2008;12(6):R160. doi: 10.1186/cc7159. Epub 2008 Dec 17. — View Citation

Kruse O, Grunnet N, Barfod C. Blood lactate as a predictor for in-hospital mortality in patients admitted acutely to hospital: a systematic review. Scand J Trauma Resusc Emerg Med. 2011 Dec 28;19:74. doi: 10.1186/1757-7241-19-74. Review. — View Citation

Pearse RM. Extending the role of lactate measurement into the prehospital environment. Crit Care. 2009;13(1):115. doi: 10.1186/cc7687. Epub 2009 Feb 10. Review. — View Citation

Rossaint R, Bouillon B, Cerny V, Coats TJ, Duranteau J, Fernández-Mondéjar E, Filipescu D, Hunt BJ, Komadina R, Nardi G, Neugebauer EA, Ozier Y, Riddez L, Schultz A, Vincent JL, Spahn DR. The European guideline on management of major bleeding and coagulopathy following trauma: fourth edition. Crit Care. 2016 Apr 12;20:100. doi: 10.1186/s13054-016-1265-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of lactate level measurement	Proportion of subjects with measured and recorded prehospital lactate level	1 day - the time the patient is treated by Emergency Medical System