Pediatric Immune Response to Multi-Organ Dysfunction

NCT ID: NCT04438460

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-29
• Study Completion Date: 2024-04-16

Brief Summary

Multiple organ dysfunction (MOD) is defined by the association of at least two failures of vital organs, with various etiologies (septic shock, polytrauma, acute respiratory distress syndrome, etc.). Associated mortality remains high in children (between 20 and 50%).

In septic shock, one of the main causes of MOD, induced immunosuppression can occur, with immune alterations affecting all cells of immunity. This induced immunosuppression is associated with an additional risk of secondary acquired infections and death in adults. Among all the cells and all the markers studied, the expression of Human Leukocyte Antigen - DR isotype (HLA-DR) on the surface of the monocyte (mHLA-DR, expressed in number of sites per cell) appeared as one of the best biomarkers of this induced immunosuppression. Decreased expression of monocyte Human Leukocyte Antigen - DR isotype (mHLA-DR) in adults is linked to an increased risk of developing secondary infection and death.

These results were confirmed by team in the context of pediatric septic shock, with an attack of innate immunity in the foreground. Persistent lowering of mHLA-DR for more than 3 days after onset of shock was associated with the occurrence of secondary acquired infections: 50% of children had mHLA-DR of less than 8000 sites / cells on D3, of which 60 % developed secondary infection within 30 days. No child with mHLA-DR greater than 8000 sites / cells had secondary infection.

Such immune alterations appear to be non-specific for septic shock, as they have also been described after multiple trauma or severe respiratory infections.

The hypothesize is that multi-systemic aggression leading to multi-visceral failure syndrome could also lead to significant immunosuppression, regardless of the etiology of this MOD.

At present, the proportion of persistent immunosuppression induced by MOD, all etiologies combined, is poorly documented in pediatrics. Estimating this proportion in a large pediatric cohort, while exploring as fully as possible the associated immune alterations and acquired secondary infections, would improve the pathophysiological understanding and pediatric specificities of this phenomenon.

Conditions

Multiple Organ Dysfunction Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient group

150 children aged 1 month to 12 years with multi-visceral failure syndrome within 48 hours of hospitalization in pediatric resuscitation will be included in this study

Group Type: EXPERIMENTAL

Blood test

Intervention Type: BIOLOGICAL

For patient group, blood tests will be performed at day 1-2, day 3-5 and day 60.

For control group, blood test will be performed the day of elective surgery.

Control group

60 children aged 1 month to 12 years hospitalized for simple elective surgery will be included in this study

Group Type: OTHER

Blood test

Intervention Type: BIOLOGICAL

For patient group, blood tests will be performed at day 1-2, day 3-5 and day 60.

For control group, blood test will be performed the day of elective surgery.

Interventions

Blood test

For patient group, blood tests will be performed at day 1-2, day 3-5 and day 60.

For control group, blood test will be performed the day of elective surgery.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Patient Group:

• 1 month < Age < 12 years
• Multiple organ dysfunction within 48 hours following intensive care unit admission
• Beneficiary of a social security scheme.
• Consent signed by at least one parent / holder of parental authority

Control Group:

• 1 month < Age < 12 years
• Hospitalized for simple elective surgery
• Beneficiary of a social security scheme.
• Consent signed by at least one parent / holder of parental authority

Exclusion Criteria

Patient Group:

• Weight < 5 kg
• Known immunosuppression
• Prolonged corticotherapy
• Chronic inflammatory disease
• Malignant pathology with ongoing treatment
• Hepatic cirrhosis
• Polymerase Chain Reaction (PCR) Severe acute respiratory syndrome coronavirus (SARS-CoV-2) positive or patient with Pediatric Inflammatory Multisystem Syndrome (PIMS)
• Pediatric inflammatory multisystem syndrome (PIMS)

Control Group:

• Weight < 5 kg
• Known immunosuppression
• Prolonged corticotherapy
• Chronic inflammatory disease
• Malignant pathology with ongoing treatment
• Ongoing infection
• Organ failure
• Hepatic cirrhosis
• PCR SARS-CoV-2 positive or patient with Pediatric Inflammatory Multisystem Syndrome (PIMS)
• Pediatric inflammatory multisystem syndrome (PIMS)

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Femme Mère Enfant

Bron, , France

Hopital Mère Enfant

Nantes, , France

Countries

France

Other Identifiers

2020-A00343-36

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL20_0068

Identifier Type: -

Identifier Source: org_study_id