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Longitudinal Prospective Study in a Mixed ICU Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03714230
Recruitment Status : Enrolling by invitation
First Posted : October 22, 2018
Last Update Posted : October 22, 2018
South-Eastern Norway Regional Health Authority
University of California, San Francisco
University of Copenhagen
Information provided by (Responsible Party):
Tone Rustøen, Oslo University Hospital

Brief Summary:
Longitudinal prospective observational study in a mixed population of intensive care unit (ICU) patients (n=500). 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.

Condition or disease
Intensive Care Patients

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).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Trajectory of Functional Status During the First Year After ICU Admission.
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : December 1, 2020

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. The investigation of 5 pre-selected symptoms during the ICU stay [ Time Frame: September 2018 - December 2020 ]
    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.

  2. Cognitive functioning one year after ICU admission in a mixed ICU population [ Time Frame: September 2018 - December 2020 ]
    Cognitive functioning will be measured using self-report with the Cognitive Failure Questionnaire.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The sample population is adults patients admitted to the ICU.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03714230

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Oslo Univesity hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
South-Eastern Norway Regional Health Authority
University of California, San Francisco
University of Copenhagen
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Principal Investigator: Tone Rustøen, Professor Oslo University Hospital and Oslo University

Additional Information:

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Responsible Party: Tone Rustøen, Professor, Oslo University Hospital Identifier: NCT03714230     History of Changes
Other Study ID Numbers: 2017/990
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tone Rustøen, Oslo University Hospital:
Functional status, Symptoms, Cognitive functioning, QOL