Clinical trial NCT03714230: Longitudinal Prospective Study in a Mixed ICU Population
Official title: The Trajectory of Functional Status During the First Year After ICU Admission.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Patients
Keywords: Functional status, Symptoms, Cognitive functioning, QOL
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
name: University of California, San Francisco
name: University of Copenhagen
First posted: 2018-10-22
Enrollment: 603
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The sample population is adults patients admitted to the ICU.

Brief 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 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).

Eligibility criteria: Inclusion Criteria

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: A cohort study on change of Functional Status during the first year after an ICU admission
timeFrame: September 2018- May 2020
Secondary outcomes:
measure: The investigation of 5 pre-selected symptoms during the ICU stay
timeFrame: September 2018 - December 2020
measure: Cognitive functioning one year after ICU admission in a mixed ICU population
timeFrame: September 2018 - December 2020
measure: Posttraumatic Stress Symptoms one year after ICU admission in a mixed ICU population, and the importance of hope
timeFrame: January 2020 - December 2021
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Univesity hospital
Study officials:
affiliation: Oslo University Hospital and Oslo University
name: Tone Rustøen, Professor
role: PRINCIPAL_INVESTIGATOR
References: