Postintensive Care SyndromePreMed4PICSNCT05518786
Precision Medicine for Post-Intensive Care Syndrome (PreMed4PICS)
An observational study of Postintensive Care Syndrome, run by Fundación para la Investigación Biosanitaria del Principado de Asturias at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postintensive Care Syndrome
- What is being tested?
- Exposure of interest: critical illness
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2020to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU of three different tertiary university hospitals
Who may be able to join
- Patients admitted to ICU
Who cannot join
- Neurocritical patients
- Previous neurocognitive or muscular impairments
- Immunosuppression
- Known neoplasia
- Terminal illness
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Central de Asturias (HUCA)
Oviedo, Principality of Asturias, 33011
Laura Amado-Rodríguez, MD, PhD, +34 985652433, lar@crit-lab.org
Laura Amado-Rodríguez, MD, PhD
About this study
Official title: Precision Medicine for Post-Intensive Care Syndrome (PreMed4PICS): Pathogenetic Phenotypes in Skeletal Muscle Weakness and Transcriptomic Signatures for Long-term Sequelae
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.
Read the detailed description
The main objective of this project is to demonstrate that transcriptomic profiling of the acute systemic inflammatory response in patients admitted to the ICU predicts the main molecular pathways activated in the skeletal muscle at the onset of critical illness and during recovery, and the long term post-ICU sequelae. To achieve this objective the following specific aims have been established and organized into four work packages (WP) with specific objectives:
WP1: Clinical subphenotying and sampling in a large cohort of critically ill patients.
WP1.1. To characterize clinical features of the acute response to critical illness in two independents cohorts.
WP1.2. To evaluate long-term post-ICU sequelae after ICU discharge. WP1.3. To create a biobanked collection of samples from critically-ill patients.
WP2: Pathogenetic subphenotyping of skeletal muscle injury and recovery in critically ill patients.
WP2.1. To perform sn-RNAseq in muscle samples obtained at ICU admission and during the recovery phase from patients with and without persistent postICU muscle weakness.
WP2.2. To identify local pathogenetic subphenotypes according to the mechanisms involved in ICUAW development and recovery.
WP3: Transcriptomic profiling of peripheral whole blood during the acute response to critical illness.
WP3.1. To massively sequence gene expression and c-miRNA in peripheral blood obtained at ICU admission (discovery cohort).
WP3.2. To identify transcriptomic signatures in peripheral blood predictive of pathogenetic muscular phenotypes and long-term post-ICU sequelae.
WP3.3. To characterize the acute inflammatory profiles in response to critical illness according to the transcriptomic signatures.
- Conditions
- Postintensive Care Syndrome
- Being tested
- Exposure of interest: critical illness
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure of interest: critical illnessOther
Patients admitted to an intensive care unit (ICU) will be followed-up to evaluate post-ICU long-term sequelae
| Study group | Role | What they receive |
|---|---|---|
| HUCA | Patients recruited at the University Central Hospital of Oviedo Receives: Other: Exposure of interest: critical illness | |
| Taulí | Patients recruited at Parc Taulí Foundation/Hospital (Sabadell) Receives: Other: Exposure of interest: critical illness | |
| Paz | Patients recruited at University Hospital of La Paz (Madrid) Receives: Other: Exposure of interest: critical illness |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU-acquired weakness
Presence or absence of muscle weakness after critical illness at 12 months after ICU discharge.
Measured: 1 year
Neurocognitive impairment
Presence or absence of neurocognitive impairment in survivors of critical illness at 12 months after ICU discharge
Measured: 1 year
Secondary outcomes (1)
All-cause mortality
All-cause mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 May 2020
- Primary completion30 Dec 2023 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postintensive Care SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación Biosanitaria del Principado de Asturias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518786
- Sponsor's protocol ID
- CritLab_6
- Acronym
- PreMed4PICS
- Status last verified
- Oct 2023
- First submitted
- 25 Aug 2022
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data Management Plan will be implemented and followed-up during the project respecting the legal data privacy requirements in accordance with the General Data Protection Regulation 2016/679/EU (GDPR). Ethical principles will be rigorously respected. Genomic data will be shared in agreement with the Genomics Declaration. PreMed4PICS investigators will strive to make the data generated "FAIR", Findable, Accessible, Interoperable, and Reusable: * Clinical data will be collected in RedCap, under the current legislation for this sensitive information. All recordings will be anonimized, and a master file linking anonymized data with patient IDs will be kept inside the hospital network. * The code used to analyze will be shared at the public repository GitHub. All the code will be programmed in R language (open source).
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine for Post-Intensive Care Syndrome (PreMed4PICS): Pathogenetic Phenotypes in Skeletal Muscle Weakness and Transcriptomic Signatures for Long-term Sequelae
- ClinicalTrials.gov ID
- NCT05518786
- Acronym / sponsor ID
- PreMed4PICS / CritLab_6
- Conditions
- Postintensive Care Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundación para la Investigación Biosanitaria del Principado de AsturiasUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main objective of this project is to demonstrate that transcriptomic profiling of the acute systemic inflammatory response in patients admitted to the ICU predicts the main molecular pathways activated in the skeletal muscle at the onset of critical illness and during recovery, and the long term post-ICU sequelae. To achieve this objective the following specific aims have been established and organized into four work packages (WP) with specific objectives:
WP1: Clinical subphenotying and sampling in a large cohort of critically ill patients.
WP1.1. To characterize clinical features of the acute response to critical illness in two independents cohorts.
WP1.2. To evaluate long-term post-ICU sequelae after ICU discharge. WP1.3. To create a biobanked collection of samples from critically-ill patients.
WP2: Pathogenetic subphenotyping of skeletal muscle injury and recovery in critically ill patients.
WP2.1. To perform sn-RNAseq in muscle samples obtained at ICU admission and during the recovery phase from patients with and without persistent postICU muscle weakness.
WP2.2. To identify local pathogenetic subphenotypes according to the mechanisms involved in ICUAW development and recovery.
WP3: Transcriptomic profiling of peripheral whole blood during the acute response to critical illness.
WP3.1. To massively sequence gene expression and c-miRNA in peripheral blood obtained at ICU admission (discovery cohort).
WP3.2. To identify transcriptomic signatures in peripheral blood predictive of pathogenetic muscular phenotypes and long-term post-ICU sequelae.
WP3.3. To characterize the acute inflammatory profiles in response to critical illness according to the transcriptomic signatures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HUCA | – | Other: Exposure of interest: critical illnessPatients recruited at the University Central Hospital of Oviedo |
| Taulí | – | Other: Exposure of interest: critical illnessPatients recruited at Parc Taulí Foundation/Hospital (Sabadell) |
| Paz | – | Other: Exposure of interest: critical illnessPatients recruited at University Hospital of La Paz (Madrid) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU of three different tertiary university hospitals
Key inclusion criteria (1 listed)
- Patients admitted to ICU
Key exclusion criteria (5 listed)
- Neurocritical patients
- Previous neurocognitive or muscular impairments
- Immunosuppression
- Known neoplasia
- Terminal illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure of interest: critical illnessPatients admitted to an intensive care unit (ICU) will be followed-up to evaluate post-ICU long-term sequelae | Other | HUCA, Paz, Taulí |
Primary outcome
ICU-acquired weakness
Time frame: 1 year
Presence or absence of muscle weakness after critical illness at 12 months after ICU discharge.
Neurocognitive impairment
Time frame: 1 year
Presence or absence of neurocognitive impairment in survivors of critical illness at 12 months after ICU discharge
1 secondary outcome
All-cause mortality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: Yes. Data Management Plan will be implemented and followed-up during the project respecting the legal data privacy requirements in accordance with the General Data Protection Regulation 2016/679/EU (GDPR). Ethical principles will be rigorously respected. Genomic data will be shared in agreement with the Genomics Declaration. PreMed4PICS investigators will strive to make the data generated "FAIR", Findable, Accessible, Interoperable, and Reusable: * Clinical data will be collected in RedCap, under the current legislation for this sensitive information. All recordings will be anonimized, and a master file linking anonymized data with patient IDs will be kept inside the hospital network. * The code used to analyze will be shared at the public repository GitHub. All the code will be programmed in R language (open source).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postintensive Care Syndrome, run by Fundación para la Investigación Biosanitaria del Principado de Asturias at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU-acquired weakness (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.