Examining immune dysfunction in critically ill patients

Cuantificación de la Disfunción Inmunitaria Inducida Por la Enfermedad Crítica Mediante el Estudio de un Panel de Genes y Moléculas Implicadas en la Sinapsis Inmunológica y su Utilidad Pronóstica

This study is trying to see how the immune system works in critically ill patients in the ICU to find out if they have weakened immunity and to help create a test to check their immune health.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Valladolid (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Valladolid)
• Trial ID: NCT05954260 on ClinicalTrials.gov

What this trial studies

This observational study investigates the immune responses of critically ill patients, focusing on the balance between systemic inflammatory response syndrome (SIRS) and compensatory anti-inflammatory response syndrome (CARS). It aims to identify the prevalence of functional immunosuppression in patients admitted to the ICU by analyzing a panel of genes and molecules involved in the immunological synapse through blood sampling. The study seeks to establish a diagnostic test to determine the functional immunocompetence of patients at a specific time point during their critical illness.

Who should consider this trial

Good fit: Ideal candidates for this study are critically ill patients aged 18 and older who exhibit organ failure as indicated by a SOFA score of 4 or higher.

Not a fit: Patients who have received pharmacological immunosuppression within the last three months or have pre-existing immunodeficiencies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic capabilities for assessing immune function in critically ill patients, potentially reducing the risk of opportunistic infections.

How similar studies have performed: While the approach of assessing immune dysfunction in critical illness is established, this specific methodology and focus on immunological synapse genes is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Failure of one or more organs, assessed by a Sequential Organ Failure Assessment Score (SOFA) ≥4 within the first 24 hours of admission to the Intensive Care Unit (ICU). At least one of the physiological systems involved must be in the category of organ failure and, therefore, score ≥3.
* Informed consent to participate in the study.
* Age equal to or greater than 18 years.

Exclusion Criteria:

* Pharmacological immunosuppression within the 3 months prior to the current admission date, including treatment with corticosteroids, immunosuppressive drugs (conventional or biological), or chemotherapy.
* Immunodeficiency.
* Age under 18 years.
* Absence of consent to participate in the study.

Where this trial is running

Valladolid

• Hospital Universitario Río Hortega — Valladolid, Spain (RECRUITING)

Study contacts

• Principal investigator: David Pérez-Torres, MD — Hospital Universitario Río Hortega, Universidad de Valladolid
• Study coordinator: David Pérez-Torres, MD

Conditions: Critical Illness