Longitudinal Prospective Study in a Mixed ICU Population

NCT ID: NCT03714230

Last Updated: 2022-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 603 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-08
• Study Completion Date: 2021-06-01

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).

Conditions

Intensive Care Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tone Rustøen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tone Rustøen, Professor

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital and Oslo University

Locations

Oslo Univesity hospital

Oslo, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 37812229 (View on PubMed)

Other Identifiers

2017/990

Identifier Type: -

Identifier Source: org_study_id