Is Invasive ICU-treatment Associated With Mental Illness?

Sponsor
Uppsala University (Other)
Overall Status
Completed
CT.gov ID
NCT05137977
Collaborator
(none)
1,048,576
72

Study Details

Study Description

Brief Summary

Understanding long-term complications after intensive care is important to be able to offer prophylactic and therapeutic measures to post-intensive care unit (ICU) patients.

Since patients in the ICU experience life threatening conditions, severe psychological and physical stress, we hypothesized that patients after ICU have an increased risk of mental illnesses specifically anxiety disorders, depression and post-traumatic stress disorder (PTSD). Moreover, we hypothesized that the prevalence and severity of mental illnesses are related to the extent of intensive care.

Our endpoints are the prevalence of anxiety disorders, depression one year after ICU-care and if the extent of intensive care an independent predictor of psychiatric illness one year after ICU admission.

We will assess Swedish Intensive Care registry data for all adult ICU patients admitted between 2010-2015 and assess ICD-10 codes for anxiety disorders, depression and PTSD one year after ICU admission.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intensive Care

Detailed Description

Background

As intensive care unit (ICU)-mortality rates are improving in many areas, research focus has turned towards sequelae after ICU-care. The term Post Intensive Care Syndrome has been coined, concluding a high frequency of mental illness, cognitive and physical impairment immediately after ICU-care. Since patients in the ICU experience life threatening conditions, severe psychological and physical stress, we hypothesize that patients after ICU have an increased risk of long-term mental illnesses that increase with the extent of intensive care, specifically anxiety, and post-traumatic stress disorder (PTSD). Current data on the extent and severity of mental illness after intensive care, and if intensive care is an independent predictor of it, is limited.

Objective

Our objective is to assess in nationwide data if extensive ICU-treatment contributes to mental illness. Extensive ICU-treatment will be defined in our dataset as ICU-treatment of patients in need of invasive ventilation, and/or continuous renal replacement therapy (CRRT). Our endpoints are prevalence of mental illness one year after discharge, and its association between extent of ICU-treatment.

Method

We will use the Swedish intensive Care registry of intensive care patients treated between 2010 and 2015 for extracting data on Data on Invasive ventilation treatment, CRRT-treatment, gender and age. ICD-10 codes corresponding for anxiety, PTSD and depression, and other diagnoses known to increase the risk of mental illness will be extracted from the Swedish National Patient Registry. Patients younger than 18 years old and ICU-codes corresponding for pre-existing anxiety, PTSD, depression, and treatment periods less than 24 hours will be excluded from the study. Missing data will be imputed. A multivariable regression model will be fit using ICU-codes corresponding with mental illness as dependent variable, Invasive ventilation and CRRT as independent variables, and the other parameters as covariates.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
1048576 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official Title:
Is Invasive ICU-treatment Associated With Mental Illness?
Actual Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Dec 31, 2015
Actual Study Completion Date :
Dec 31, 2015

Arms and Interventions

Arm Intervention/Treatment
SIR

All adult intensive care patients. Data from the The Swedish intensive care registry

Procedure: Intensive Care
Invasive ventilation more than 24hs.
Other Names:
  • CRRT
  • Invasive ventilation
  • Outcome Measures

    Primary Outcome Measures

    1. Mental illness [2010-2015]

      Defined as PTSD, depressive symptoms or anxiety or combination of the earlier mentioned.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • 18 years old
    Exclusion Criteria:
    • ICD codes for previous mental illness.

    • ICU stay less than 24 hours

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Uppsala University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Uppsala University
    ClinicalTrials.gov Identifier:
    NCT05137977
    Other Study ID Numbers:
    • RBM2021
    First Posted:
    Nov 30, 2021
    Last Update Posted:
    Nov 30, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 30, 2021