Longitudinal Prospective Study in a Mixed ICU Population

NCT03714230 | Completed

• 1 other identifier: 2017/990
• Study Type: observational
• Target: 603
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Patients

Keywords

Functional status, Symptoms, Cognitive functioning, QOL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The investigation of 5 pre-selected symptoms during the ICU stay

  September 2018 - December 2020

• Cognitive functioning one year after ICU admission in a mixed ICU population

  September 2018 - December 2020

• Posttraumatic Stress Symptoms one year after ICU admission in a mixed ICU population, and the importance of hope

  January 2020 - December 2021

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The sample population is adults patients admitted to the ICU.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• South-Eastern Norway Regional Health Authority: collaborator
• University of California, San Francisco: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Oslo Univesity hospital

Oslo, 0424, Norway

Location

Related Publications (1)

• Saltnes-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.

  PMID: 37812229 DERIVED

Study Officials

• Tone Rustøen, Professor

  Oslo University Hospital and Oslo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 22, 2018
• Study Start: October 8, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: January 12, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)