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NCT05954260: EFIMERO
Immune Dysfunction in Critical Illness: Utility of a Panel of Genes and Molecules Involved in the Immunological Synapse
trial testing Blood sampling in Critical Illness in 100 participants. Status unknown.
31 December 2024
Quick facts
| Lead sponsor | David Pérez Torres |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 20 August 2023 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Blood sampling — full drug profile →
Conditions studied
- Critical Illness — all drugs for Critical Illness →
Sponsor
David Pérez Torres
Who can join
18 and older, any sex, with Critical Illness. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05954260
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05954260 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by David Pérez Torres
- Last refreshed: 23 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05954260.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing