NCT03115970

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

April 14, 2017

Status Verified

April 1, 2017

Enrollment Period

3 months

First QC Date

April 9, 2017

Last Update Submit

April 12, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Trauma patients

All patients having / suspected to have severe trauma injuries

Procedure: capillary and venous lactate level measurement

Interventions

capillary and venous lactate level measurement

Trauma patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient having / suspected to have severe trauma

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 22202128BACKGROUND
  • 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.

    PMID: 19091118BACKGROUND
  • 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.

    PMID: 19232076BACKGROUND
  • 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.

    PMID: 27072503BACKGROUND

MeSH Terms

Conditions

Multiple TraumaHyperlactatemia

Condition Hierarchy (Ancestors)

Wounds and InjuriesMetabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marcela Bilska, Dr.

    Masaryk Hospital in Usti nad Labem

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcela Bilska, Dr.

CONTACT

Josef Skola, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 9, 2017

First Posted

April 14, 2017

Study Start

May 1, 2017

Primary Completion

July 31, 2017

Study Completion

December 31, 2017

Last Updated

April 14, 2017

Record last verified: 2017-04