Feasibility of Lactate Level Evaluation in Prehospital Care in Trauma

April 12, 2017 updated by: Marcela Bilska, Masaryk Hospital Usti nad Labem
Capillary or venous lactate level evaluation in prehospital care could be simple and beneficial tool for optimising prehospital care in patients with severe trauma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient having / suspected to have severe trauma

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trauma patients
All patients having / suspected to have severe trauma injuries
Procedure: capillary and venous lactate level measurement
capillary and venous lactate level measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of lactate level measurement
Time Frame: 1 day - the time the patient is treated by Emergency Medical System
Proportion of subjects with measured and recorded prehospital lactate level
1 day - the time the patient is treated by Emergency Medical System

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masaryk Hospital Usti nad Labem

Investigators

  • Principal Investigator: Marcela Bilska, Dr., Masaryk hospital in Usti nad Labem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2017

Primary Completion (Anticipated)

July 31, 2017

Study Completion (Anticipated)

December 31, 2017

Study Registration Dates

First Submitted

April 9, 2017

First Submitted That Met QC Criteria

April 12, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

April 14, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAPIM-L

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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