Trauma, MultipleNCT03115970
Feasibility of Lactate Level Evaluation in Prehospital Care in Trauma
An observational study of Trauma, Multiple and Lactate Blood Increase, run by Masaryk Hospital Usti nad Labem.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Multiple, Lactate Blood Increase
- What is being tested?
- capillary and venous lactate level measurement
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2017to 31 Dec 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient having / suspected to have severe trauma
Who may be able to join
- patient having / suspected to have severe trauma treated by cooperating Emergency Medical System organization
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Trauma, Multiple, Lactate Blood Increase
- Being tested
- capillary and venous lactate level measurement
- Medical subject headings
- Multiple Trauma, Hyperlactatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capillary and venous lactate level measurementProcedure or surgery
capillary and venous lactate level measurement
| Study group | Role | What they receive |
|---|---|---|
| Trauma patients | All patients having / suspected to have severe trauma injuries Receives: Procedure: capillary and venous lactate level measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of lactate level measurement
Proportion of subjects with measured and recorded prehospital lactate level
Measured: 1 day - the time the patient is treated by Emergency Medical System
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start1 May 2017 (estimated)
- Primary completion31 Jul 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Trauma, MultipleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Masaryk Hospital Usti nad Labem
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcela Bilska, Masaryk Hospital Usti nad Labem
- Investigators
- Marcela Bilska, Dr., Principal investigator, Masaryk Hospital in Usti nad Labem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115970
- Sponsor's protocol ID
- KAPIM-L
- Status last verified
- Apr 2017
- First submitted
- 9 Apr 2017
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 22202128Jansen 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 19091118Pearse 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 19232076Rossaint 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Lactate Level Evaluation in Prehospital Care in Trauma
- ClinicalTrials.gov ID
- NCT03115970
- Acronym / sponsor ID
- KAPIM-L
- Conditions
- Trauma, Multiple, Lactate Blood Increase
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Masaryk Hospital Usti nad LabemUniversity, hospital or other
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 31 Jul 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Capillary or venous lactate level evaluation in prehospital care could be simple and beneficial tool for optimising prehospital care in patients with severe trauma.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma patients | – | Procedure: capillary and venous lactate level measurementAll patients having / suspected to have severe trauma injuries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient having / suspected to have severe trauma
Key inclusion criteria (1 listed)
- patient having / suspected to have severe trauma treated by cooperating Emergency Medical System organization
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capillary and venous lactate level measurementcapillary and venous lactate level measurement | Procedure or surgery | Trauma patients |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Background: PubMed 22202128Kruse 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.
- Background: PubMed 19091118Jansen 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.
- Background: PubMed 19232076Pearse 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.
- Background: PubMed 27072503Rossaint 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcela Bilska, Dr. principal investigator
Masaryk Hospital in Usti nad Labem
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, Multiple and Lactate Blood Increase, run by Masaryk Hospital Usti nad Labem.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcela Bilska, Dr. (+420723715208, marcela.bilska@kzcr.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of lactate level measurement (time frame: 1 day - the time the patient is treated by Emergency Medical System). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03115970, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.