SepsisLAPHSUSNCT03831685
Blood Lactate Level for Pre-hospital Orientation of Septic Shock
An observational study of Sepsis and Lactate Blood Increase, run by Hôpital Necker-Enfants Malades at 1 site in France.
Trial summary
In the pre-hospital setting, the severity assessment of septic shock is essential to decide the optimal initial in-hospital level of care. As clinical signs can be faulted, there is a need for an additional element in order to enhance the severity assessment and to decide in-hospital admission in the intensive care… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Lactate Blood Increase
- What is being tested?
- Blood sample
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2018to 1 Mar 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with septic shock in the pre-hospital setting requiring mobile intensive care unit intervention
Who may be able to join
- Age > 18 years either sex
- Severe sepsis according to the French anesthesiology and intensive care society (SFAR) and intensive care society (SRLF) conference 2005 defined by the existence of an infectious disease and at least one the following:
- Low blood pressure prior to volume expansion
- Glasgow coma scale < 13
- Skin mottling score > 2
- Septic shock according to the French anesthesiology and intensive care society (SFAR) and intensive care society (SRLF) conference 2005 definition
Who cannot join
- Age < 18 years
- Pregnancy
- Serious comorbid conditions with a not to be reanimated status known since pre-hospital setting
- Patients with guardianship or curator
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
APHP Necker Enfants Malades
Paris, 75015
Romain Jouffroy, MD, +3314495989, romain.jouffroy@aphp.fr
Benoit Vivien, MD, PhD, +33144492424, benoit.vivien@aphp.fr
About this study
Official title: Contribution of Pre-hospital Blood Lactate Level for Pre-hospital Orientation of Septic Shock
In the pre-hospital setting, the severity assessment of septic shock is essential to decide the optimal initial in-hospital level of care. As clinical signs can be faulted, there is a need for an additional element in order to enhance the severity assessment and to decide in-hospital admission in the intensive care unit (ICU) or in the emergency department (ED). Point of care medical device yielding blood lactate levels since the pre-hospital setting may give an easy and valuable element for the severity assessment and the decision-making.
The aim of this study is to provide clinical evidence that the pre-hospital blood lactate level predicts the 30-day mortality of patients with septic shock.
Read the detailed description
This trial is a prospective, observational, non-randomized controlled study. A total of 1000 patients requiring mobile intensive care unit intervention for a septic shock in the pre-hospital setting will be included. Pre-hospital blood lactate levels will not be taken into account to decide patients treatments and/or ED or ICU admission. In the pre-hospital setting, each patient will benefit from 2 measurements of blood lactate level: initial measurement at the first contact, and final measurement at the hospital admission with a specific point of care medical device.
- Conditions
- Sepsis, Lactate Blood Increase
- Being tested
- Blood sample
- Keywords
- sepsis, lactate, prehospital, prediction, mortality
- Medical subject headings
- Sepsis, Hyperlactatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Patients meeting the inclusion criteria and none of the non-inclusion criteria will benefit from 2 venous blood samples in order to precise the initial blood lactate level, e.g. at the first medical contact, and the final blood lactate level, e.g. at the hospital admission.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality after inclusion
mortality rate
Measured: 30 days
Secondary outcomes (5)
Intensive Care Unit length of stay
Duration of ICU length of stay
Measured: 90 days
Hospital length of stay
Duration of Hospital length of stay
Measured: 90 days
Mechanical ventilatory support
Duration of mechanical ventilation
Measured: 30 days
Hemodynamic support
Duration of catecholamines' infusion
Measured: 30 days
Duration of hemodiaflitration
Duration of extra renal support
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 Mar 2018
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Necker-Enfants Malades
- Sponsor type
- University, hospital or other
- Collaborators
- Fire Brigade Of Paris Emergency Medicine Dept, University Hospital, Grenoble, University Hospital, Toulouse, University Hospital Center of Martinique
- Responsible party
- Principal investigator, Romain Jouffroy, Hôpital Necker-Enfants Malades
- Investigators
- Romain Jouffroy, MD, Principal investigator, APHP - Necker enfants malades Hospital - SAMU Anesthesiology and intensive care unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831685
- Sponsor's protocol ID
- LAPHSUS study
- Acronym
- LAPHSUS
- Status last verified
- Feb 2019
- First submitted
- 2 Feb 2019
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Marecaux G, Pinsky MR, Dupont E, Kahn RJ, Vincent JL. Blood lactate levels are better prognostic indicators than TNF and IL-6 levels in patients with septic shock. Intensive Care Med. 1996 May;22(5):404-8. doi: 10.1007/BF01712155.
PubMed 8796390Bakker J, Coffernils M, Leon M, Gris P, Vincent JL. Blood lactate levels are superior to oxygen-derived variables in predicting outcome in human septic shock. Chest. 1991 Apr;99(4):956-62. doi: 10.1378/chest.99.4.956.
PubMed 2009802Cicarelli DD, Vieira JE, Bensenor FE. [Lactate as a predictor of mortality and multiple organ failure in patients with the systemic inflammatory response syndrome.]. Rev Bras Anestesiol. 2007 Dec;57(6):630-8. doi: 10.1590/s0034-70942007000600005. Portuguese.
PubMed 19462139Gaieski DF, Goyal M. Serum lactate as a predictor of mortality in emergency department patients with infection: does the lactate level tell the whole story? Ann Emerg Med. 2005 Dec;46(6):561-2; author reply 562. doi: 10.1016/j.annemergmed.2005.07.021. No abstract available.
PubMed 16308078Mikkelsen ME, Miltiades AN, Gaieski DF, Goyal M, Fuchs BD, Shah CV, Bellamy SL, Christie JD. Serum lactate is associated with mortality in severe sepsis independent of organ failure and shock. Crit Care Med. 2009 May;37(5):1670-7. doi: 10.1097/CCM.0b013e31819fcf68.
PubMed 19325467Shapiro NI, Howell MD, Talmor D, Nathanson LA, Lisbon A, Wolfe RE, Weiss JW. Serum lactate as a predictor of mortality in emergency department patients with infection. Ann Emerg Med. 2005 May;45(5):524-8. doi: 10.1016/j.annemergmed.2004.12.006.
PubMed 15855951Arnold RC, Shapiro NI, Jones AE, Schorr C, Pope J, Casner E, Parrillo JE, Dellinger RP, Trzeciak S; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Multicenter study of early lactate clearance as a determinant of survival in patients with presumed sepsis. Shock. 2009 Jul;32(1):35-9. doi: 10.1097/shk.0b013e3181971d47.
PubMed 19533847
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Pre-hospital Blood Lactate Level for Pre-hospital Orientation of Septic Shock
- ClinicalTrials.gov ID
- NCT03831685
- Acronym / sponsor ID
- LAPHSUS / LAPHSUS study
- Conditions
- Sepsis, Lactate Blood Increase
- Keywords
- sepsis, lactate, prehospital, prediction, mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hôpital Necker-Enfants MaladesUniversity, hospital or other
- Collaborators
- Fire Brigade Of Paris Emergency Medicine Dept, University Hospital, Grenoble, University Hospital, Toulouse, University Hospital Center of Martinique
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 6 Feb 2019 (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.
In the pre-hospital setting, the severity assessment of septic shock is essential to decide the optimal initial in-hospital level of care. As clinical signs can be faulted, there is a need for an additional element in order to enhance the severity assessment and to decide in-hospital admission in the intensive care unit (ICU) or in the emergency department (ED). Point of care medical device yielding blood lactate levels since the pre-hospital setting may give an easy and valuable element for the severity assessment and the decision-making.
The aim of this study is to provide clinical evidence that the pre-hospital blood lactate level predicts the 30-day mortality of patients with septic shock.
Detailed description
This trial is a prospective, observational, non-randomized controlled study. A total of 1000 patients requiring mobile intensive care unit intervention for a septic shock in the pre-hospital setting will be included. Pre-hospital blood lactate levels will not be taken into account to decide patients treatments and/or ED or ICU admission. In the pre-hospital setting, each patient will benefit from 2 measurements of blood lactate level: initial measurement at the first contact, and final measurement at the hospital admission with a specific point of care medical device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with septic shock in the pre-hospital setting requiring mobile intensive care unit intervention
Key inclusion criteria (6 listed)
- Age > 18 years either sex
- Severe sepsis according to the French anesthesiology and intensive care society (SFAR) and intensive care society (SRLF) conference 2005 defined by the existence of an infectious disease and at least one the following:
- Septic shock according to the French anesthesiology and intensive care society (SFAR) and intensive care society (SRLF) conference 2005 definition
Key exclusion criteria (4 listed)
- Age < 18 years
- Pregnancy
- Serious comorbid conditions with a not to be reanimated status known since pre-hospital setting
- Patients with guardianship or curator
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 |
|---|---|---|
| Blood samplePatients meeting the inclusion criteria and none of the non-inclusion criteria will benefit from 2 venous blood samples in order to precise the initial blood lactate level, e.g. at the first medical contact, and the final blood lactate level, e.g. at the hospital admission. | Other | – |
Primary outcome
Mortality after inclusion
Time frame: 30 days
mortality rate
5 secondary outcomes
Intensive Care Unit length of stay
Time frame: 90 days
Hospital length of stay
Time frame: 90 days
Mechanical ventilatory support
Time frame: 30 days
Hemodynamic support
Time frame: 30 days
Duration of hemodiaflitration
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Background: PubMed 8796390Marecaux G, Pinsky MR, Dupont E, Kahn RJ, Vincent JL. Blood lactate levels are better prognostic indicators than TNF and IL-6 levels in patients with septic shock. Intensive Care Med. 1996 May;22(5):404-8. doi: 10.1007/BF01712155.
- Background: PubMed 2009802Bakker J, Coffernils M, Leon M, Gris P, Vincent JL. Blood lactate levels are superior to oxygen-derived variables in predicting outcome in human septic shock. Chest. 1991 Apr;99(4):956-62. doi: 10.1378/chest.99.4.956.
- Background: PubMed 19462139Cicarelli DD, Vieira JE, Bensenor FE. [Lactate as a predictor of mortality and multiple organ failure in patients with the systemic inflammatory response syndrome.]. Rev Bras Anestesiol. 2007 Dec;57(6):630-8. doi: 10.1590/s0034-70942007000600005. Portuguese.
- Background: PubMed 16308078Gaieski DF, Goyal M. Serum lactate as a predictor of mortality in emergency department patients with infection: does the lactate level tell the whole story? Ann Emerg Med. 2005 Dec;46(6):561-2; author reply 562. doi: 10.1016/j.annemergmed.2005.07.021. No abstract available.
- Background: PubMed 19325467Mikkelsen ME, Miltiades AN, Gaieski DF, Goyal M, Fuchs BD, Shah CV, Bellamy SL, Christie JD. Serum lactate is associated with mortality in severe sepsis independent of organ failure and shock. Crit Care Med. 2009 May;37(5):1670-7. doi: 10.1097/CCM.0b013e31819fcf68.
- Background: PubMed 15855951Shapiro NI, Howell MD, Talmor D, Nathanson LA, Lisbon A, Wolfe RE, Weiss JW. Serum lactate as a predictor of mortality in emergency department patients with infection. Ann Emerg Med. 2005 May;45(5):524-8. doi: 10.1016/j.annemergmed.2004.12.006.
- Background: PubMed 19533847Arnold RC, Shapiro NI, Jones AE, Schorr C, Pope J, Casner E, Parrillo JE, Dellinger RP, Trzeciak S; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Multicenter study of early lactate clearance as a determinant of survival in patients with presumed sepsis. Shock. 2009 Jul;32(1):35-9. doi: 10.1097/shk.0b013e3181971d47.
- 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.
Romain Jouffroy, MD principal investigator
APHP - Necker enfants malades Hospital - SAMU Anesthesiology and intensive care unit
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 and Lactate Blood Increase, run by Hôpital Necker-Enfants Malades 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 6 inclusion and 4 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 11 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romain Jouffroy, MD (+33144495989, romain.jouffroy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality after inclusion (time frame: 30 days). 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 NCT03831685, which also lists 7 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 11 Feb 2019.