Leukocyte MOrphology and CORticosteroids Response in SEPtic Patients (MOCORSEP)

NCT04292431 | Completed

• 1 other identifier: MOCORSEP_BEC_2019
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

Non-interventional, prospective, monocentric study on the exploration of leukocyte morphological parameters according to the infectious condition and response to corticosteroid therapy of septic patients.

Conditions

Sepsis; Septic Shock; Sepsis Syndrome; Infection

Keywords

Leukocyte morphology; Corticosteroid; MDW; Cell population data; DxH900

Outcome Measures

Primary Outcomes (1)

• Leukocytes morphological parameters differs between patient's groups

  The leukocytes morphological parameters determined by DxH900 (CPD and MDW) will be compared between the patient's groups in the cohort: * patients with infection * patients with sepsis * patients with septic shock * patients with septic shock responding to corticosteroid treatment * patients with septic shock not responding to corticosteroid treatment

  7 days

Secondary Outcomes (2)

• Leukocytes morphological parameters preditcs inflammatory status

  7 days

• Leukocytes morphological parameters preditcs responce to corticosteroids treatments

  7 days

Eligibility Criteria

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

Study Population

Non infected (n=50) Infection (n=50) Sepsis + SOFA \> 2 (n=25) Sepsis (SOFA \> 2) + vasopressors and lactate ≤ 2 mmol/L (n=25) Septic shock (SOFA \> 2 + vasopressor + lactate \> 2 mmol/L) (n=25)

You may qualify if:

• an infection (known or suspected)
• sepsis
• sepsis + vasopressor
• septic shock
• responders to corticosteroid therapy
• non-responders to corticosteroid therapy

You may not qualify if:

• Pregnant women
• Patients with onco-hematological diseases with the presence of blasts.

Sponsors & Collaborators

• Beckman Coulter, Inc.: lead
• Hôpital Raymond Poincaré: collaborator
• Saint-Louis Hospital, Paris, France: collaborator

Study Sites (1)

Hospital Raymond Poincaré

Garches, Paris, 92380, France

Location

Related Publications (4)

• Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, Francois B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohe J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.

  PMID: 29490185 BACKGROUND

• Annane D, Sebille V, Charpentier C, Bollaert PE, Francois B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troche G, Chaumet-Riffaud P, Bellissant E. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA. 2002 Aug 21;288(7):862-71. doi: 10.1001/jama.288.7.862.

  PMID: 12186604 BACKGROUND

• Crouser ED, Parrillo JE, Seymour C, Angus DC, Bicking K, Tejidor L, Magari R, Careaga D, Williams J, Closser DR, Samoszuk M, Herren L, Robart E, Chaves F. Improved Early Detection of Sepsis in the ED With a Novel Monocyte Distribution Width Biomarker. Chest. 2017 Sep;152(3):518-526. doi: 10.1016/j.chest.2017.05.039. Epub 2017 Jun 15.

  PMID: 28625579 BACKGROUND

• Crouser ED, Parrillo JE, Seymour CW, Angus DC, Bicking K, Esguerra VG, Peck-Palmer OM, Magari RT, Julian MW, Kleven JM, Raj PJ, Procopio G, Careaga D, Tejidor L. Monocyte Distribution Width: A Novel Indicator of Sepsis-2 and Sepsis-3 in High-Risk Emergency Department Patients. Crit Care Med. 2019 Aug;47(8):1018-1025. doi: 10.1097/CCM.0000000000003799.

  PMID: 31107278 BACKGROUND

MeSH Terms

Conditions

Sepsis; Shock, Septic; Systemic Inflammatory Response Syndrome; Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Djillali Annane, MD

  Hospital Raymond Poincaré

  PRINCIPAL INVESTIGATOR

• Pierre Moine, MD

  Hospital Raymond Poincaré

  STUDY CHAIR

• Martin Rottman, MD

  Hospital Raymond Poincaré

  STUDY CHAIR

• Sylvie Chevret, MD

  Hospital Saint Louis Lariboisière Fernand-Widal

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 3, 2020
• Study Start: November 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: December 30, 2020
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)