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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04292431
Other study ID # MOCORSEP_BEC_2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date December 30, 2020

Study information

Verified date January 2021
Source Beckman Coulter, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

Sepsis is a major public health issue, caused by an organ disorder related to an immune response not controlled by the infection. Several randomized trials have shown that the combination of glucocorticoids and mineralocorticoids improves the survival rate of patients in septic shock. The optimal use of this therapeutic approach requires identifying the pro-inflammatory phase patients likely to respond to corticosteroid therapy. Hyperactivation of immune cells is accompanied by morphological changes likely to be characterized by modern hematology instruments, particularly the DxH900 (Beckman Coulter). The DxH900 is able to use specific techniques to determine a significant number of morphological characteristics (CPD or Cell Population Data) for circulating leukocytes. Recently, one of these leukocyte morphological parameters, MDW (Monocyte Distribution Width), has been clinically approved for identifying septic patients or those at risk of developing sepsis. This MDW parameter currently has the CE IVD mark and is approved by the American FDA. The aim of the study is to explore the hypothesis that leukocyte morphological parameters, including MDW, may constitute functional biomarkers of pro-inflammatory response and help to identify septic patients likely to optimally respond to a combination treatment of glucocorticoids and mineralocorticoids, and thus improve their chances of survival. The proposed study is a non-interventional, prospective, monocentric cohort study to explore the variation of leukocyte morphological parameters measured on the DxH900 hematology analyzer according to the different infectious conditions of patients ranging from a known or suspected infection to septic shock versus non-infected control patients, and possibly based on the response. This observational cohort study will consist of patients with a known or suspected infection, sepsis or in septic shock on their date of admission into one of the medical or surgical departments and monitored up to day 7 of the hospital stay or on the date of discharge from the hospital, whichever occurs first.


Recruitment information / eligibility

Status Completed
Enrollment 175
Est. completion date December 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - an infection (known or suspected) - sepsis - sepsis + vasopressor - septic shock - responders to corticosteroid therapy - non-responders to corticosteroid therapy Exclusion Criteria: - Pregnant women - Patients with onco-hematological diseases with the presence of blasts.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hospital Raymond Poincaré Garches Paris

Sponsors (3)

Lead Sponsor Collaborator
Beckman Coulter, Inc. Hôpital Raymond Poincaré, Saint-Louis Hospital, Paris, France

Country where clinical trial is conducted

France, 

References & 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, François B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohé 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. — View Citation

Annane D, Sébille V, Charpentier C, Bollaert PE, François B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troché 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. Erratum in: JAMA. 2008 Oct 8;300(14):1652. Chaumet-Riffaut, Philippe [corrected to Chaumet-Riffaud, Philippe]. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Leukocytes morphological parameters preditcs inflammatory status Identify whether the CPD parameters differ between patients with a pro-inflammatory state for those presenting signs of immunosuppression 7 days
Secondary Leukocytes morphological parameters preditcs responce to corticosteroids treatments Explore the relevance of CPD parameters for predicting and monitoring the response to corticosteroid therapy in patients with septic shock. 7 days
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