SepsisNCT01964690
Lactate Use as Triage Tool in Sepsis : Veinous, Capillary or Arterial?
An observational study of Sepsis, run by Hopital Saint Roch at 1 site in France.
Trial summary
Severe sepsis and septic shocks are increasingly codified. A biomarker as Lactate is very interesting to detect those situations. Usually, lactate used is arterial but results are often too slow to obtain if we want to respect Surviving Sepsis Campaign guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Apr 2014
- 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: Patients with suspected infection in emergency department (admission time)
Who may be able to join
- Age >18 years
- S.I.R.S : 2 or more criteria (fever > 38.3°C or hypothermia (core temperature < 36°C) heart rate > 90.min-1, tachypnea, altered mental status)
- Suspected infection
Who cannot join
- Arterial sample by laboratory reference method no available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lactate and Sepsis : What Dosage Use as Triage Tool in Emergency Department for Patients With Suspected Infection.
Severe sepsis and septic shocks are increasingly codified. A biomarker as Lactate is very interesting to detect those situations. Usually, lactate used is arterial but results are often too slow to obtain if we want to respect Surviving Sepsis Campaign guidelines. Some analyzers (EKF diagnostics Lactate Scout*) can give results in 15 seconds.
We hypothesized that capillary lactate, easy to sample, tested with this analyzer may detect earlier those infections states and we want to find the most accurate site to detect severe sepsis (capillary, venous or arterial sample).
Read the detailed description
Actually, patients presenting a sepsis with arterial lactate> 2 mmol.l-1 must be considered as criticals, and if lactate> 4 mmol.l-1 as septic shock. However, results are usually slow to obtain, especially if we want to respect the Surving Sepsis Campaign, which preconize antibiotic as soon as possible (first hour).
In admission room, arterial sample can't be easily done and usual results need more than 30 minutes. On the contrary, using analyzers like "EKF diagnostics Lactate Scout*" can give results faster with capillary blood (15 seconds). We will compare this results with both veinous and arterial lactate.
- For primary outcome, we will determine the most accurate value of capillary or veinous lactate that may be able to detect critical patient suspected of infection.
- for secondary outcomes, we will determine if quick capillary lactate test may replace arterial lactate in this indication and be able to predict mortality.
- Conditions
- Sepsis
- Keywords
- Lactate, Sepsis, Capillary lactate, Venous lactate, Quick test
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate value
Determine the most accurate value of capillary or venous lactate that may be able to early detect patients with severe sepsis or septic shock, using quick test (EKF diagnostics Lactate scout*).
Measured: At admission in emergency department
Secondary outcomes (2)
Comparison values of capillary lactate and arterial lactate
Determine if capillary blood lactate may replace laboratory reference method (arterial lactate)
Measured: 30 minutes after sampling
Mortality
Determine if capillary lactate value can be use as a mortality predictive tool
Measured: Day 28 mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Saint Roch
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Contenti Julie, Hopital Saint Roch
- Investigators
- Contenti Julie, M.D, Principal investigator, Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des UrgencesJacques Levraut, PD,MD, Study director, CHU de Nice, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964690
- Sponsor's protocol ID
- CAL2013
- Other IDs
- 2013-AO1293-42
- Status last verified
- Jan 2014
- First submitted
- 15 Oct 2013
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Contenti J, Corraze H, Lemoel F, Levraut J. Effectiveness of arterial, venous, and capillary blood lactate as a sepsis triage tool in ED patients. Am J Emerg Med. 2015 Feb;33(2):167-72. doi: 10.1016/j.ajem.2014.11.003.
PubMed 25432592
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactate and Sepsis : What Dosage Use as Triage Tool in Emergency Department for Patients With Suspected Infection.
- ClinicalTrials.gov ID
- NCT01964690
- Acronym / sponsor ID
- CAL2013
- Conditions
- Sepsis
- Keywords
- Lactate, Sepsis, Capillary lactate, Venous lactate, Quick test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Hopital Saint RochUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Oct 2013 (estimated)
- 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.
Severe sepsis and septic shocks are increasingly codified. A biomarker as Lactate is very interesting to detect those situations. Usually, lactate used is arterial but results are often too slow to obtain if we want to respect Surviving Sepsis Campaign guidelines. Some analyzers (EKF diagnostics Lactate Scout*) can give results in 15 seconds.
We hypothesized that capillary lactate, easy to sample, tested with this analyzer may detect earlier those infections states and we want to find the most accurate site to detect severe sepsis (capillary, venous or arterial sample).
Detailed description
Actually, patients presenting a sepsis with arterial lactate> 2 mmol.l-1 must be considered as criticals, and if lactate> 4 mmol.l-1 as septic shock. However, results are usually slow to obtain, especially if we want to respect the Surving Sepsis Campaign, which preconize antibiotic as soon as possible (first hour).
In admission room, arterial sample can't be easily done and usual results need more than 30 minutes. On the contrary, using analyzers like "EKF diagnostics Lactate Scout*" can give results faster with capillary blood (15 seconds). We will compare this results with both veinous and arterial lactate.
- For primary outcome, we will determine the most accurate value of capillary or veinous lactate that may be able to detect critical patient suspected of infection.
- for secondary outcomes, we will determine if quick capillary lactate test may replace arterial lactate in this indication and be able to predict mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected infection in emergency department (admission time)
Key inclusion criteria (3 listed)
- Age >18 years
- S.I.R.S : 2 or more criteria (fever > 38.3°C or hypothermia (core temperature < 36°C) heart rate > 90.min-1, tachypnea, altered mental status)
- Suspected infection
Key exclusion criteria (1 listed)
- Arterial sample by laboratory reference method no available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lactate value
Time frame: At admission in emergency department
Determine the most accurate value of capillary or venous lactate that may be able to early detect patients with severe sepsis or septic shock, using quick test (EKF diagnostics Lactate scout*).
2 secondary outcomes
Comparison values of capillary lactate and arterial lactate
Time frame: 30 minutes after sampling
Mortality
Time frame: Day 28 mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
- Derived from this study: PubMed 25432592Contenti J, Corraze H, Lemoel F, Levraut J. Effectiveness of arterial, venous, and capillary blood lactate as a sepsis triage tool in ED patients. Am J Emerg Med. 2015 Feb;33(2):167-72. doi: 10.1016/j.ajem.2014.11.003.
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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.
Contenti Julie, M.D principal investigator
Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
Jacques Levraut, PD,MD study director
CHU de Nice, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Hopital Saint Roch at 1 site in France.
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 3 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: finished, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactate value (time frame: At admission in emergency department). 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 NCT01964690, which also lists 1 linked publication.
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 29 Apr 2014.