Precision Medicine for Post-Intensive Care Syndrome (PreMed4PICS)

NCT05518786 | Unknown

• 1 other identifier: CritLab_6
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• ICU-acquired weakness

  Presence or absence of muscle weakness after critical illness at 12 months after ICU discharge.

  1 year

• Neurocognitive impairment

  Presence or absence of neurocognitive impairment in survivors of critical illness at 12 months after ICU discharge

  1 year

Secondary Outcomes (1)

• All-cause mortality

  1 year

Study Arms (3)

HUCA

Patients recruited at the University Central Hospital of Oviedo

Other: Exposure of interest: critical illness

Taulí

Patients recruited at Parc Taulí Foundation/Hospital (Sabadell)

Other: Exposure of interest: critical illness

Paz

Patients recruited at University Hospital of La Paz (Madrid)

Other: Exposure of interest: critical illness

Interventions

Exposure of interest: critical illness OTHER

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

HUCA; Paz; Taulí

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to the ICU of three different tertiary university hospitals

You may qualify if:

• Patients admitted to ICU

You may not qualify if:

• Neurocritical patients
• Previous neurocognitive or muscular impairments
• Immunosuppression
• Known neoplasia
• Terminal illness

Sponsors & Collaborators

• Fundación para la Investigación Biosanitaria del Principado de Asturias: lead

Study Sites (1)

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and skeletal muscle

MeSH Terms

Conditions

postintensive care syndrome

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: May 1, 2020
• Primary Completion: December 30, 2023
• Study Completion: May 31, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available after public release of results, for at least 3 years after sharing.

Locations

ES (1)