Pro-inflammatory Role of Blood Platelets in Critically Ill Patients With Septic Shock.

NCT04080453 | Completed

• 1 other identifier: CHUBX 2017/20
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

Blood platelets play a major role in the inflammatory response. A dysregulation of platelets activation may be one of the contributors to tissue damage in critically ill patients with septic shock. The main objective of this study is to compare platelet activation markers levels (including plasma concentration in CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha and HMGB-1) at the early phase of a septic shock and a systemic inflammatory response syndrome (SIRS).

Conditions

Septic Shock

Keywords

Blood platelets; CD40 ligand; Multiple Organ Failure

Outcome Measures

Primary Outcomes (1)

• Plasma concentration

  Plasma concentration in CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha and HMGB-1 will be measured in each group by dosage

  Day 0, day 1 and day 5

Secondary Outcomes (7)

• Neutrophil Extracellular Traps formation

  Day 0, day 1 and day 5

• Markers of platelet activation and severity of organ failure

  Day 0 and Day 7

• Markers of platelet activation and inflammatory markers

  Day 0 and Day 7

• Markers of platelet activation and ISTH score

  Day 0

• Markers of platelet activation and platelet count

  Day 0 and day 7

Study Arms (2)

Septic shock

Plasma of 100 patients presenting a septic shock will be analysed including plasma concentration in CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha and HMGB-1

Other: Septic shock

Systemic Inflammatory Response Syndrome

Plasma of 100 patient presenting a systemic inflammatory response syndrome = SIRS will be analysed including plasma concentration in CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha and HMGB-1

Other: Systemic Inflammatory Response Syndrome

Interventions

Septic shock OTHER

Plasma concentration in CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha, HMGB-1, monocyte Dnases signal, circulating free DNA and DNase1 and DNase1L3 activities will be studied and compared at inclusion (Day 0), Day 1 and Day 5.

Septic shock

Systemic Inflammatory Response Syndrome OTHER

Plasma concentration in CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha, HMGB-1, monocyte Dnases signal, circulating free DNA and DNase1 and DNase1L3 activities will be studied and compared at inclusion (Day 0), Day 1 and Day 5.

Systemic Inflammatory Response Syndrome

Eligibility Criteria

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

Study Population

In this study, two populations will be recruiting, patients presenting a septic shock and patient presenting a SIRS, who will be admitted in intensive care unit or in continuing care units.

You may qualify if:

• Patients aged over 18 years admitted to an intensive care unit for:
• a septic shock evolving for less than 24h (defined by an increase in the SOFA (Sequential Organ Failure Assessment) score of at least 2 points related to an infection, a persisting hypotension requiring vasopressors to maintain MAP ≥65 mmHg and a serum lactate level \>2 mmol/L (18 mg/dL) despite adequate volume resuscitation)
• Or a systemic inflammatory response syndrome (SIRS) evolving for less than 24h (defined as 2 or more of the following variables: fever of more than 38°C or less than 36°C, heart rate of more than 90 beats per minute, respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension (PaCO2) of less than 32 mm Hg, abnormal white blood cell count (\>12,000/µL or \<4,000/µL or \>10% immature forms).

You may not qualify if:

• Age \< 18 years
• Known history of constitutional thrombopathy (Bernard Soulier's disease, Glanzmann thrombasthenia, Gray's syndrome or dense granule disease)
• Myeloproliferative or myelodysplastic syndrome
• Autoimmune thrombocytopenic purpura
• Acute leukemia
• Haemorrhagic shock
• Active HIV infection or known active hepatitis B or C
• Pregnant or breastfeeding woman
• Patients protected by the law, under guardianship or trusteeship, or deprived of liberty
• Patients without health insurance

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• MSD France: collaborator

Study Sites (1)

Hôpital Haut Lévêque

Pessac, 33604, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Shock, Septic; Hyper-IgM Immunodeficiency Syndrome; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Dysgammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Antoine DEWITTE, Dr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: November 9, 2020
• Primary Completion: February 9, 2024
• Study Completion: April 25, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

FR (1)