Immune Dysfunction in Critical Illness: Utility of a Panel of Genes &

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Critical Illness

Clinical Trial Details

NCT number	NCT05954260
Study type	Observational
Source	University of Valladolid
Contact	David Pérez-Torres, MD
Phone	983420400
Email	inmunologia-criticos@saludcastillayleon.onmicrosoft.com
Status	Recruiting
Phase
Start date	August 20, 2023
Completion date	December 31, 2025

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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.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms