Blood Lactate Level for Pre-hospital Orientation of Septi... | NCT03831685

Studies
Blood Lactate Level for Pre-hospital Orientation of Septic Shock

NCT03831685

Sponsor

Hôpital Necker-Enfants Malades

Status

Unknown status

Last Update Posted

Feb 11, 2019Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Sepsis
Lactate Blood Increase

Interventions

Blood sample

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2018Actual

Primary Completion Date

Mar 1, 2022Estimated

Completion Date

Mar 1, 2022Estimated

First Submitted Date

Feb 2, 2019

First Submission Date that Met QC Criteria

Feb 4, 2019

First Posted Date

Feb 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2019

Last Update Posted Date

Feb 11, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Romain Jouffroy, PI, Hôpital Necker-Enfants MaladesPrincipal Investigator

Lead Sponsor

Hôpital Necker-Enfants MaladesOTHER

Collaborators

Name	Class
Fire Brigade Of Paris Emergency Medicine Dept	OTHER
University Hospital, Grenoble	OTHER
University Hospital, Toulouse	OTHER
University Hospital Center of Martinique

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sample	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality after inclusion	mortality rate	30 days

Secondary Outcomes

Measure	Description	Time Frame
Intensive Care Unit length of stay	Duration of ICU length of stay	90 days
Hospital length of stay	Duration of Hospital length of stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Age < 18 years
Pregnancy
Serious comorbid conditions with a not to be reanimated status known since pre-hospital setting
Patients with guardianship or curator

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with septic shock in the pre-hospital setting requiring mobile intensive care unit intervention

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Romain Jouffroy, MD	Contact	+33144495989		romain.jouffroy@gmail.com
Benoit Vivien, MD, PhD	Contact	+3314492424		benoit.vivien@aphp.fr

Overall Officials

Name	Affiliation	Role
Romain Jouffroy, MD	APHP - Necker enfants malades Hospital - SAMU Anesthesiology and intensive care unit	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
APHP Necker Enfants Malades	Recruiting	Paris		75015	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8796390	Background	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.
2009802	Background	Bakker 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.

ID	Term
D018805	Sepsis
D065906	Hyperlactatemia

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis