Other Clinical Trial - Pediatric Immune Response to Multi-Organ

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Multiple Organ Dysfunction Syndrome
Multiple Organ Failure

Clinical Trial Details

NCT number	NCT04438460
Study type	Interventional
Source	Hospices Civils de Lyon
Contact
Status	Completed
Phase	N/A
Start date	July 29, 2020
Completion date	April 16, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00430859` - Bovine Intestinal Alkaline Phosphatase for the Treatment of Patients With Sepsis	Phase 2
Recruiting	`NCT01713205` - Prediction Study of Complications After Severe Trauma
Recruiting	`NCT01186783` - Reducing Elevated Heart Rate in Patients With Multiple Organ Dysfunction Syndrome (MODS) by Ivabradine	Phase 2
Terminated	`NCT03489577` - The Role of Post-traumatic Inhibition of the Innate and Adaptive Immune System in the Development of Infectious Complications in Severely Injured Patients
Recruiting	`NCT00908635` - The Role of Angiopoietin, Tie-2, and Vascular Endothelial Growth Factor (VEGF) in Sepsis-Induced Multiple Organ Dysfunction Syndrome (MODS)	N/A
Recruiting	`NCT04014413` - Safety and Efficacy of Fecal Microbiota Transplantation	N/A
Recruiting	`NCT03552848` - Mesenchymal Stem Cells for Multiple Organ Dysfuntion Syndrome After Surgical Repaire of Acute Type A Aortic Dissection	N/A
Enrolling by invitation	`NCT02204215` - Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients	N/A
Recruiting	`NCT01802983` - The Prognostic Assessment of Extubation in Aged Patients With Multiple Organ Dysfunction Syndrome	N/A
Completed	`NCT03019250` - A Trial of Enteral Colostrum on Clinical Outcomes in Critically Ill Patients	N/A
Terminated	`NCT01787045` - Early Physical Therapy in Patients With Sepsis	N/A
Completed	`NCT02246036` - Tolerance and Safety of a Duodenal Probe Monitoring the Microcirculation	N/A
Completed	`NCT03518203` - Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome -Associated Multiple Organ Dysfunction Syndrome in Hematopoietic Stem Cell Transplant Recipients	Phase 2
Completed	`NCT00736723` - NT-proBNP in ICU Postoperative/Posttraumatic Patients With Shock	N/A
Completed	`NCT00736827` - BK Virus and Renal Dysfunction in Postoperative/Posttraumatic Critically Ill Patients	N/A
Recruiting	`NCT00127985` - 6-Methyl-Prednisolone for Multiple Organ Dysfunction Syndrome	Phase 4
Recruiting	`NCT03589378` - Therapeutic Plasma Exchange Adsorption Diafiltration	N/A
Terminated	`NCT01275976` - Effect of C1-esterase Inhibitor on Systemic Inflammation in Trauma Patients With a Femur or Pelvic Fracture	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pediatric Immune Response to Multi-Organ Dysfunction — PedIMOD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms