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Status unknownNCT03115970Updated Apr 14, 2017

Feasibility of Lactate Level Evaluation in Prehospital Care in Trauma

An observational study in Trauma, Multiple and Lactate Blood Increase, sponsored by Masaryk Hospital Usti nad Labem. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-14.

Sponsored by Masaryk Hospital Usti nad Labem · Observational

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Trauma, Multiple
  • Lactate Blood Increase
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patient having / suspected to have severe trauma

Inclusion criteria

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

Exclusion criteria

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)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Trauma patients

    All patients having / suspected to have severe trauma injuries

    Procedure: capillary and venous lactate level measurement

Interventions

  • Procedurecapillary and venous lactate level measurement

    capillary and venous lactate level measurement

05

What researchers measure

Primary outcomes

  1. Feasibility of lactate level measurement

    Proportion of subjects with measured and recorded prehospital lactate level

    Time frame: 1 day - the time the patient is treated by Emergency Medical System

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 22202128 ↗
  • 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. PubMed 19091118 ↗
  • 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. PubMed 19232076 ↗
  • Rossaint R, Bouillon B, Cerny V, Coats TJ, Duranteau J, Fernandez-Mondejar 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. PubMed 27072503 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03115970
Lead sponsor
Masaryk Hospital Usti nad Labem
Responsible party
Marcela Bilska (Dr., Masaryk Hospital Usti nad Labem) — Principal investigator
First posted
Apr 14, 2017
Start date
May 1, 2017 (estimated)
Primary completion
Jul 31, 2017 (estimated)
Completion
Dec 31, 2017 (estimated)
Last update
Apr 14, 2017

Study contacts

Marcela Bilska, Dr.
Contact
marcela.bilska@kzcr.eu
+420723715208
Josef Skola, Dr.
Contact
josef.skola@kzcr.eu
+42060547711406
Marcela Bilska, Dr.
principal investigator · Masaryk Hospital in Usti nad Labem

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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