Metrology to Enable Rapid and Accurate Clinical Measurements in Acute Management of Sepsis

NCT05338359 | Unknown

• 2 other identifiers: APHP1910162021-A01612-39
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis is a life-threatening condition that arises when a dysregulated response to infection results in multi-organ dysfunction or failure. This can affect any organ, resulting in a diverse clinical presentation. Sepsis affects more than 3.4 million Europeans a year with 700,000 deaths from the condition and an additional one third of survivors dying through complications in the year following a sepsis event. To date, biomarkers that are used to predict bacterial infection (such as CRP or lactate) are used in combination and with other clinical symptoms due to the fact that they are non-specific for sepsis. The use of such biomarkers frequently varies between hospitals or even physicians. Biomarkers such as procalcitonin (PCT) have been reported as useful for differentiating between infectious and non-infectious causes of systemic inflammatory response syndrome. Yet calibration of PCT assays is problematic due to the absence of higher order method or international standard. External quality assessment (EQA) programs have highlighted poor comparability. This protocol is part of the international SEPTIMET project. The Emergency Department (ED) of the Pitié-Salpêtrière hospital takes part of the project with specific objectives in order to establish a large cohort of patients at very early stage sepsis (defined by Systemic Inflammatory Response Syndrome -SIRS - due to bacterial infection or the first symptoms of sepsis before septic shock, patients consulting in the first hours of the history of the disease at the emergency department) with the idea of spotting the condition before it manifests as a more serious presentation. This will measure the clinical criteria and putative biomarkers as patients progress to more serious presentation. Moreover, an expected biobank of \>200 samples will be generated to provide material for the Laboratoire National de Métrologie et d'essais (LNE) in charge of analytical studies.

Conditions

Sepsis Syndrome

Keywords

Procalcitonin; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Procalcitonin (PCT) measurements in serum assessed by Isotope dilution coupled to high-performance liquid chromatography and mass spectrometry

  Day 0

Secondary Outcomes (4)

• Procalcitonin (PCT) measurements in serum assessed by standard immunoassay technique

  Day 0

• Calculation of Systemic Inflammatory Response Syndrome (SIRS) score

  Day 0

• Calculation of quick Sequential Organ Failure Assessment (qSOFA) score

  Day 0

• Calculation of Sequential Organ Failure Assessment (SOFA) score

  Day 0

Interventions

Blood sample BIOLOGICAL

Blood sample of 34 mL

Phone-call OTHER

Phone-call to the participant 15 days after recruitment to fix the final diagnosis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending the ED, suspected to have bacterial infection by the emergency physician after clinical exam, and requiring a blood sampling.

You may qualify if:

• Patient attending the ED, suspected to have bacterial infection by the emergency physician after clinical exam, and requiring a blood sampling in the ED,
• Ages Eligible for Study: 18 to 100 years-old
• PCT prescribed by physician
• Non-opposition obtained from the patient or, if not capable to express his/her non-opposition, a trustworthy person, a family member or a close relative.
• For the collection of biological samples and subsequent genetic analysis, informed consent signed by the patient

You may not qualify if:

• Patient minor under 18
• Pregnancy
• Anticipated difficulties for the follow-up at D15 (homeless...)
• Previously enrolled in this study (i.e. subjects may not be enrolled more than
• Patient with positive serology (HIV, HBV, HCV…)
• Patient without Social Security
• Refusal to participate from the patient or, if not capable to express himself/herself, a trustworthy person, a family member or a close relative
• Patient under guardianship or curatorship
• Patient deprived of their liberty by a judicial or administrative decision

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Laboratoire National de Métrologie et d'essais: collaborator
• Commissariat A L'energie Atomique: collaborator

Study Sites (1)

Pitié-Salpêtrière hospital / Emergency Department

Paris, 75013, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Laetitia VELLY, MD

  GH Pitié Salpêtrière - Charles Foix

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laetitia VELLY, MD

CONTACT

+33184828136; laetitia.velly@aphp.fr

Pierre HAUSFATER, MD

CONTACT

pierre.hausfater@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: April 21, 2022
• Study Start: January 25, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: April 21, 2022

Record last verified: 2022-01

Locations

FR (1)