Longitudinal Prospective Study in a Mixed ICU Population

Intensive Care Patients Clinical Trial

Official title:

The Trajectory of Functional Status During the First Year After ICU Admission.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03714230
• Other study ID #: 2017/990
• Status: Completed
• Start date: October 8, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: April 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 functional status during first year after an ICU admission.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 603
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Patients

Locations

Country	Name	City	State
Norway	Oslo Univesity hospital	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Oslo University Hospital	South-Eastern Norway Regional Health Authority, University of California, San Francisco, University of Copenhagen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	September 2018- May 2020
Secondary	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.	September 2018 - December 2020
Secondary	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.	September 2018 - December 2020
Secondary	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.	January 2020 - December 2021