Immune Dysfunction in Critical Illness: Utility of a Panel of Genes and Molecules Involved in the Immunological Synapse

NCT05954260 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-08-23

No results posted yet for this study

Summary

Critical illnesses represent a significant physiological assault that triggers changes in the patient's immune system, resulting in an immunopotentiating response (systemic inflammatory response syndrome, SIRS) and an immunosuppressive response (compensatory anti-inflammatory response syndrome, CARS). The balance between SIRS and CARS is essential for the patient to return to a state of immune homeostasis and accelerate the healing process. However, when CARS is disproportionately intense, it leads to a state of immunoparalysis, which predisposes the patient to vulnerability to opportunistic infections, associated with a peak in late mortality. The majority of patients admitted to the ICU are considered immunocompetent. However, the investigators suspect that a significant proportion of them exhibit predominance of CARS and a state of functional immunosuppression. There is currently no diagnostic test to determine whether a patient is functionally immunocompetent at a specific point in time.

The goal of this observational study is to learn about the immune system dysfunction occurring in critical illness. The main questions it aims to answer are:

* What is the prevalence of immune system dysfunction in critical illness?
* Does immune system dysfunction affect multiple organ failure trajectory and mortality in critical illness?
* Is immune system dysfunction related to an increased risk of opportunistic hospital-acquired infections in critical illness?
* Is immune system dysfunction related to age, fragility, nutritional status or previous comorbidities in critical illness?

To answer these questions, the investigators will prospectively study a population of critically ill patients, defined by the presence of organ failure. The investigators will analyse a panel of genes and molecules involved in immunological synapse, using peripheral blood samples at different moments of the evolution of critical illness. Based on the analysis, the investigators will classify the patients' functional immune status and correlate it with the outcomes.

Conditions

  • Critical Illness

Interventions

DIAGNOSTIC_TEST

Blood sampling

We will collect blood samples from the patients included in the study on ICU days 1, 3 and 5. We will measure gene expression (mRNA) and plasma levels of various elements involved in the immunological synapse.

Sponsors & Collaborators

  • Hospital del Rio Hortega

    collaborator OTHER
  • Sanidad de Castilla y León

    collaborator OTHER
  • Instituto de Investigación Biomédica de Salamanca

    collaborator OTHER
  • Fundación Española del Enfermo Crítico (FEEC)

    collaborator UNKNOWN
  • Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC)

    collaborator UNKNOWN
  • David Pérez Torres

    lead OTHER

Principal Investigators

  • David Pérez-Torres, MD · Hospital Universitario Río Hortega, Universidad de Valladolid

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-20
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05954260 on ClinicalTrials.gov