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Completed

NCT Number: NCT03714230

Longitudinal Prospective Study in a Mixed ICU Population

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo Univesity hospital

Oslo, 0424, Norway

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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, and proxy reported by IQCODE and CFQ at baseline.

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

    Time frame: January 2020 - December 2021

    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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • South-Eastern Norway Regional Health Authority
  • University of California, San Francisco
  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2018
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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