Flow Cytometry Analysis of the Reactive Oxygen Species in Immature Granulocytes in Septic Patient

NCT03846596 | Terminated

• 1 other identifier: 87RI18-0031 (SEPSIROS)
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Early during sepsis course, immature neutrophils could be found in the bloodstream and may be less efficient than mature neutrophils in reactive oxygen species (ROS) production. ROS induce an oxidative stress for bacteria which can protect through the SOS response. The main objective is to evaluate the level of ROS produced in the early steps of sepsis by the immature neutrophils.

Conditions

Sepsis

Keywords

Sepsis; reactive oxygen species; immature neutrophils

Outcome Measures

Primary Outcomes (1)

• ROS level by Flow cytometry in immature granulocytes dosage sepsis

  The biological variable obtained is an average of fluorescence intensity (MFI) corresponding to the amount of ROS contained in the immature granulocytes from the onset of sepsis to the acute phase

  Day 1

Secondary Outcomes (6)

• ROS level by Flow cytometry in mature granulocytes dosage sepsis

  Day 1

• Bacterial phagocytosis capacity of granulocytes assess by flow cytometry

  Day 1

• SOS response activation by bacteria determined by flow cytometry

  Day 1

• Hospital mortality

  Day 28

• ROS level by Flow cytometry in monocyte dosage sepsis

  Day 1

Study Arms (1)

Evaluated

An additional blood tube will be taken from patients hospitalized in intensive care or emergency department for acute sepsis

Biological: Additional blood tube

Interventions

Additional blood tube BIOLOGICAL

Additional blood tube during care

Evaluated

Eligibility Criteria

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

Study Population

Patient hospitalized in intensive car or emergency department for acute sepsis

You may qualify if:

• Adult patients hospitalized in ICU or ED for acute sepsis

You may not qualify if:

• Immunosupressed patients
• Active cancer
• HIV
• Hematological or inflammatory diseases

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Limoges university Hospital

Limoges, 87042, France

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas DAIX, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 19, 2019
• Study Start: March 26, 2019
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)