Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
Study NCT ID:
NCT05954260
Status:
RECRUITING
Last Update Posted:
2023-08-23
First Post:
2023-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immune Dysfunction in Critical Illness: Utility of a Panel of Genes and Molecules Involved in the Immunological Synapse
Sponsor:
David Pérez Torres
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EFIMERO
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: