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Precision Medicine for Post-Intensive Care Syndrome (PreMed4PICS)

NCT05518786 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-10-05

No results posted yet for this study

Summary

Critically ill patients show an acute phase characterized by systemic spread of the inflammatory response, irrespectively of the cause of intensive care unit (ICU) admission, and late sequelae, including ICU acquired muscle weakness (ICUAW) and neurocognitive impairment. Mechanisms driving these late sequelae are unknown and there are no effective therapies to date. PreMed4PICS hypothesis is that skeletal muscle pathogenetic phenotypes and long-term sequelae in survivors to critical illness can be predicted at ICU admission in peripheral blood samples by transcriptomic profiling of the acute systemic response. Our main objective is to identify pathogenesis-dependent predictive signatures of muscle injury and clinical outcomes such as ICUAW or cognitive impairment. A multicentric prospective observational study will be conducted including adult patients admitted to the ICU and followed up until 12 months after ICU discharge. This will allow for clinical subphenotyping, sample acquisition and histopathological studies. To identify subphenotype-specific molecular pathways involved in skeletal muscle recovery, single-nuclei RNAseq will be performed. Massive sequencing of whole blood RNA and circulating microRNA at ICU admission will be performed to identify transcriptomic signatures that result in quantitative scores predictive of the outcomes of interest. All the findings will be confirmed in two validation cohorts. Collectively, this project aims to characterize the molecular mechanisms leading to ICUAW development and recovery, identifying therapeutic targets. The potential of a quantitative approach to the acute inflammatory response to predict long-term sequelae in survivors of critical illness will be validated.

Conditions

  • Postintensive Care Syndrome

Interventions

OTHER

Exposure of interest: critical illness

Patients admitted to an intensive care unit (ICU) will be followed-up to evaluate post-ICU long-term sequelae

Sponsors & Collaborators

  • Fundación para la Investigación Biosanitaria del Principado de Asturias

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2023-12-30
Completion
2025-05-31

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 NCT05518786 on ClinicalTrials.gov