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Pediatric Immune Response to Multi-Organ Dysfunction (PedIMOD)

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Civil Hospices of Lyon

Status

Completed

Conditions

Multiple Organ Dysfunction Syndrome

Treatments

Biological: Blood test

Study type

Interventional

Funder types

Other

Identifiers

NCT04438460
69HCL20_0068
2020-A00343-36 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

186 patients

Sex

All

Ages

1 month to 12 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

186 participants in 2 patient groups

Patient group
Experimental group
Description:
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
Treatment:
Biological: Blood test
Control group
Other group
Description:
60 children aged 1 month to 12 years hospitalized for simple elective surgery will be included in this study
Treatment:
Biological: Blood test

Trial contacts and locations

2

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Central trial contact

Tiphanie Ginhoux; Solenn REMY, MD, PhD

Data sourced from clinicaltrials.gov

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