Follow upRAINCT04979741
Recovery After Intensive Care Study
An observational study of Follow up and Outcome, run by University of Genova at 1 site in Italy.
Trial summary
Post-ICU long term sequelae- defined as "post intensive care syndrome" (PICS) manifest with a wide spectrum of psychological and cognitive impairments, affecting over two-thirds of ICU survivors and leading to increased rehospitalization, health care costs, impaired quality of life (QoL), inability to return to work… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follow up, Outcome, Intensive Care Unit Syndrome
- How many people
- 196 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 1 Jan 2023
- 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
- Adult, Older adult
Study population: Patients admitted to the ICU from more than 72 hours will be consecutively included during a 2 years period
Who may be able to join
- Age ≥ 18 years;
- All patients acutely admitted in the ICU from >72 hours, for both medical and surgical pathologies.
Who cannot join
- Pregnancy;
- Refuse of consent to enrolment of patient or of the doctor required to give his approval.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico San Martino
Genova, 16100
Iole Brunetti, MD, 010/55510, brunettimed@gmail.com
About this study
Official title: Recovery After Intensive Care Study: a Single- Center Observational Study
Post-ICU long term sequelae- defined as "post intensive care syndrome" (PICS) manifest with a wide spectrum of psychological and cognitive impairments, affecting over two-thirds of ICU survivors and leading to increased rehospitalization, health care costs, impaired quality of life (QoL), inability to return to work and burden for families.
The prevalence of post-traumatic stress symptoms (PTSD), anxiety symptoms, and depression after ICU stay is high and has been demonstrated in up to 50% of post-ICU population.
Therefore, over the last years, an important effort has been made for the development of ICU aftercare and follow-up clinics with the aim to detect and to minimize post-ICU sequelae and improve outcomes. However, the utility of these follow-up programs and their effect on outcome has not been completely demonstrated.
Read the detailed description
This is a single center, prospective observational study, which will be conducted at Policlinico San Martino Hospital, Genova, Italy. Patients admitted to the ICU from more than 72 hours will be consecutively included during a 2 years period.
The primary objective is to assess the incidence of post-discharge mortality in patients admitted in ICU at 12 months.
Secondary objectives include the evaluation at 3, 6 and 12 months of outcome of patients admitted in ICU assessing QoL, anxiety, depression, PTSD, physical ability, cognitive function, sleep disorder and return to previous life; Self- and observer reported cognitive disability at 6 and 12 months after ICU discharge; prognostic factors for poor outcome, and emotional and burden of care impact on the patient's caregivers.
- Conditions
- Follow up, Outcome, Intensive Care Unit Syndrome
- Being tested
- No interventions
- Keywords
- intensive care unit, cognitive dysfunction, delirium
- Medical subject headings
- Cognitive Dysfunction, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
Observational study, no intervention is required
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the incidence of post-discharge mortality in patients admitted in ICU.
using a neuropsychological evaluation
Measured: 12 months
Secondary outcomes (2)
Cognitive outcome assessed through the MoCA scale, Montreal Cognitive Assessment
This is a scale including different tests regarding language, attention, naming giving a score from 0 (maximal cognitive dysfunction) and 30 ( no deficit)
Measured: 12 months
Cognitive outcome assessed through HADS scale (Hospital Anxiety and Depression Scale)
Questionnaire with score from 0 (no issues) to 21 (maximal abnormalities) exploring depression and anxiety
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2021
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follow upStudies 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
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Pelosi, University of Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979741
- Sponsor's protocol ID
- CER Liguria: 350/2019
- Other IDs
- Protocol approval
- Acronym
- RAI
- Status last verified
- Jul 2021
- First submitted
- 7 Jul 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available for reasonable request to the PI
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery After Intensive Care Study: a Single- Center Observational Study
- ClinicalTrials.gov ID
- NCT04979741
- Acronym / sponsor ID
- RAI / CER Liguria: 350/2019
- Conditions
- Follow up, Outcome, Intensive Care Unit Syndrome
- Keywords
- intensive care unit, cognitive dysfunction, delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 28 Jul 2021 (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.
Post-ICU long term sequelae- defined as "post intensive care syndrome" (PICS) manifest with a wide spectrum of psychological and cognitive impairments, affecting over two-thirds of ICU survivors and leading to increased rehospitalization, health care costs, impaired quality of life (QoL), inability to return to work and burden for families.
The prevalence of post-traumatic stress symptoms (PTSD), anxiety symptoms, and depression after ICU stay is high and has been demonstrated in up to 50% of post-ICU population.
Therefore, over the last years, an important effort has been made for the development of ICU aftercare and follow-up clinics with the aim to detect and to minimize post-ICU sequelae and improve outcomes. However, the utility of these follow-up programs and their effect on outcome has not been completely demonstrated.
Detailed description
This is a single center, prospective observational study, which will be conducted at Policlinico San Martino Hospital, Genova, Italy. Patients admitted to the ICU from more than 72 hours will be consecutively included during a 2 years period.
The primary objective is to assess the incidence of post-discharge mortality in patients admitted in ICU at 12 months.
Secondary objectives include the evaluation at 3, 6 and 12 months of outcome of patients admitted in ICU assessing QoL, anxiety, depression, PTSD, physical ability, cognitive function, sleep disorder and return to previous life; Self- and observer reported cognitive disability at 6 and 12 months after ICU discharge; prognostic factors for poor outcome, and emotional and burden of care impact on the patient's caregivers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU from more than 72 hours will be consecutively included during a 2 years period
Key inclusion criteria (2 listed)
- Age ≥ 18 years;
- All patients acutely admitted in the ICU from >72 hours, for both medical and surgical pathologies.
Key exclusion criteria (2 listed)
- Pregnancy;
- Refuse of consent to enrolment of patient or of the doctor required to give his approval.
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 |
|---|---|---|
| No interventionsObservational study, no intervention is required | Other | – |
Primary outcome
To assess the incidence of post-discharge mortality in patients admitted in ICU.
Time frame: 12 months
using a neuropsychological evaluation
2 secondary outcomes
Cognitive outcome assessed through the MoCA scale, Montreal Cognitive Assessment
Time frame: 12 months
Cognitive outcome assessed through HADS scale (Hospital Anxiety and Depression Scale)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: Yes. IPD will be available for reasonable request to the PI
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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 Follow up and Outcome, run by University of Genova at 1 site in Italy.
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 2 inclusion and 2 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 28 Jul 2021. 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 Italy. 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?
Contact Iole Brunetti, MD (010/5551, brunettimed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the incidence of post-discharge mortality in patients admitted in ICU. (time frame: 12 months). 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 28 Jul 2021.