Intensive Care PatientsNCT03714230
Longitudinal Prospective Study in a Mixed ICU Population
An observational study of Intensive Care Patients, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Longitudinal prospective observational multicenter study in a mixed population of intensive care unit (ICU) patients (n=650). The overall purpose of this research proposal is to increase the knowledge in how pre-morbid condition, symptoms during treatment, and selected clinical variables affect self-reported… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Patients
- How many people
- 603 participants
- Where
- 1 siteNorway
- Study dates
- 8 Oct 2018to 1 Jun 2021
- How long will I take part?
- 1 Year
- 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: The sample population is adults patients admitted to the ICU.
Who may be able to join
- Patients that are > 18 years and
- Meet the criteria of Norwegian Intensive Register (NIR) for being an intensive care patient. The criteria include any on the following criteria:
- The need of mechanical ventilation, or
- The need of continuous inotropi, or
- 24 hours or more on an ICU, when continuous monitoring is needed, or
- Dies at the ICU within the first 24 hours, or
- Transferred to another ICU within the first 24 hours
Who cannot join
- Re-admissions to the ICU (within 72 hours from last ICU discharge)
- Pre-defined cognitive deficit (e.g. dementia)
- Homeless
- Unable to read and Write Norwegian
- Not included in the study within the first 48 hours since admission to the ICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Trajectory of Functional Status During the First Year After ICU Admission.
Longitudinal prospective observational multicenter study in a mixed population of intensive care unit (ICU) patients (n=650). The overall purpose of this research proposal is to increase the knowledge in how pre-morbid condition, symptoms during treatment, and selected clinical variables affect self-reported functional status during first year after an ICU admission.
Read the detailed description
For this study data will be collected using self-report questionnaires for the long-term outcome (e.g functional status) and several covariates (e.g., cognition, anxiety and depression, PTSD, QOL, general symptoms, frailty). To retrieve baseline data from prior ICU admission, family members will be used as proxy reporters at inclusion. During treatment in the ICU, patients will be mapped for 5 pre-selected symptoms every day for 7 days, or until death or ICU discharge. Several clinical variables (e.g., SOFA score, pain score, level of sedation, mobilization, medication, mouth care) will be collected daily until maximum 7 days. Follow-up data will be collected at 3, 6 and 12 months after ICU admission using self-report questionnaires.
The predictive value of pre-morbid condition prior to ICU admission on functional status during the first year after an ICU admission will be investigated, when controlled for various clinical and demographic variables. As a secondary analyses, the present study will identify both the occurrence of symptoms as well as the severity and distress of each symptom, while in the ICU. Another secondary outcome that will be measured in this longitudinal study is the association between cognitive function one year after an ICU admission and various mental health variables (PTSD, anxiety and depression).
- Conditions
- Intensive Care Patients
- Keywords
- Functional status, Symptoms, Cognitive functioning, QOL
What is being measured
The primary outcome is the main question the study is designed to answer.
A cohort study on change of Functional Status during the first year after an ICU admission
Data on functional status will be collected using PROMS (e.g Katz index and Lawton IADL) at baseline, and then after 3, 6 and 12 months.
Measured: September 2018- May 2020
Secondary outcomes (3)
The investigation of 5 pre-selected symptoms during the ICU stay
A modified version of the Patient Symptom Survey (PSS) checklist will be used as self-report by the ICU patient when possible or by the clinical nurse as a proxy reporter.
Measured: September 2018 - December 2020
Cognitive functioning one year after ICU admission in a mixed ICU population
Cognitive functioning will be measured using self-report with the Cognitive Failure Questionnaire, and proxy reported by IQCODE and CFQ at baseline.
Measured: September 2018 - December 2020
Posttraumatic Stress Symptoms one year after ICU admission in a mixed ICU population, and the importance of hope
Posttraumatic stress symptoms will be measured using self-report with the Impact of event scale-revised questionnaire. Hope will be measured with the Herth Hope Index.
Measured: January 2020 - December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start8 Oct 2018
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intensive Care PatientsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 603 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, University of California, San Francisco, University of Copenhagen
- Responsible party
- Principal investigator, Tone Rustøen, Oslo University Hospital
- Investigators
- Tone Rustøen, Professor, Principal investigator, Oslo University Hospital and Oslo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714230
- Sponsor's protocol ID
- 2017/990
- Status last verified
- Apr 2021
- First submitted
- 26 Sep 2018
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saltnes-Lillegard C, Rustoen T, Beitland S, Puntillo K, Thoresen M, Hofso K. Subgroups of ICU patients identified by self-reported symptoms - A prospective multicenter study. Intensive Crit Care Nurs. 2024 Oct;84:103761. doi: 10.1016/j.iccn.2024.103761. Epub 2024 Jul 16.
PubMed 39018966Saltnes-Lillegard C, Rustoen T, Beitland S, Puntillo K, Hagen M, Lerdal A, Hofso K. Self-reported symptoms experienced by intensive care unit patients: a prospective observational multicenter study. Intensive Care Med. 2023 Nov;49(11):1370-1382. doi: 10.1007/s00134-023-07219-0. Epub 2023 Oct 9.
PubMed 37812229
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Trajectory of Functional Status During the First Year After ICU Admission.
- ClinicalTrials.gov ID
- NCT03714230
- Acronym / sponsor ID
- 2017/990
- Conditions
- Intensive Care Patients
- Keywords
- Functional status, Symptoms, Cognitive functioning, QOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 603 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, University of California, San Francisco, University of Copenhagen
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 22 Oct 2018 (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.
Longitudinal prospective observational multicenter study in a mixed population of intensive care unit (ICU) patients (n=650). The overall purpose of this research proposal is to increase the knowledge in how pre-morbid condition, symptoms during treatment, and selected clinical variables affect self-reported functional status during first year after an ICU admission.
Detailed description
For this study data will be collected using self-report questionnaires for the long-term outcome (e.g functional status) and several covariates (e.g., cognition, anxiety and depression, PTSD, QOL, general symptoms, frailty). To retrieve baseline data from prior ICU admission, family members will be used as proxy reporters at inclusion. During treatment in the ICU, patients will be mapped for 5 pre-selected symptoms every day for 7 days, or until death or ICU discharge. Several clinical variables (e.g., SOFA score, pain score, level of sedation, mobilization, medication, mouth care) will be collected daily until maximum 7 days. Follow-up data will be collected at 3, 6 and 12 months after ICU admission using self-report questionnaires.
The predictive value of pre-morbid condition prior to ICU admission on functional status during the first year after an ICU admission will be investigated, when controlled for various clinical and demographic variables. As a secondary analyses, the present study will identify both the occurrence of symptoms as well as the severity and distress of each symptom, while in the ICU. Another secondary outcome that will be measured in this longitudinal study is the association between cognitive function one year after an ICU admission and various mental health variables (PTSD, anxiety and depression).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The sample population is adults patients admitted to the ICU.
Key inclusion criteria (7 listed)
- Patients that are > 18 years and
- Meet the criteria of Norwegian Intensive Register (NIR) for being an intensive care patient. The criteria include any on the following criteria:
- The need of mechanical ventilation, or
- The need of continuous inotropi, or
- 24 hours or more on an ICU, when continuous monitoring is needed, or
Key exclusion criteria (5 listed)
- Re-admissions to the ICU (within 72 hours from last ICU discharge)
- Pre-defined cognitive deficit (e.g. dementia)
- Homeless
- Unable to read and Write Norwegian
- Not included in the study within the first 48 hours since admission to the ICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A cohort study on change of Functional Status during the first year after an ICU admission
Time frame: September 2018- May 2020
Data on functional status will be collected using PROMS (e.g Katz index and Lawton IADL) at baseline, and then after 3, 6 and 12 months.
3 secondary outcomes
The investigation of 5 pre-selected symptoms during the ICU stay
Time frame: September 2018 - December 2020
Cognitive functioning one year after ICU admission in a mixed ICU population
Time frame: September 2018 - December 2020
Posttraumatic Stress Symptoms one year after ICU admission in a mixed ICU population, and the importance of hope
Time frame: January 2020 - December 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Derived from this study: PubMed 39018966Saltnes-Lillegard C, Rustoen T, Beitland S, Puntillo K, Thoresen M, Hofso K. Subgroups of ICU patients identified by self-reported symptoms - A prospective multicenter study. Intensive Crit Care Nurs. 2024 Oct;84:103761. doi: 10.1016/j.iccn.2024.103761. Epub 2024 Jul 16.
- Derived from this study: PubMed 37812229Saltnes-Lillegard C, Rustoen T, Beitland S, Puntillo K, Hagen M, Lerdal A, Hofso K. Self-reported symptoms experienced by intensive care unit patients: a prospective observational multicenter study. Intensive Care Med. 2023 Nov;49(11):1370-1382. doi: 10.1007/s00134-023-07219-0. Epub 2023 Oct 9.
- Individual participant dataSharing planned: No
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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.
Tone Rustøen, Professor principal investigator
Oslo University Hospital and Oslo University
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 Intensive Care Patients, run by Oslo University Hospital at 1 site in Norway.
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 7 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: finished, as of the sponsor's last update on 12 Jan 2022. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A cohort study on change of Functional Status during the first year after an ICU admission (time frame: September 2018- May 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03714230, which also lists 2 linked publications.
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 12 Jan 2022.