Is Invasive ICU-treatment Associated With Mental Illness?

November 16, 2021 updated by: Uppsala University

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

1048576

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Nationwide registry of patients admitted to ICU treatment in Sweden.

Description

Inclusion Criteria:

  • 18 years old

Exclusion Criteria:

  • ICD codes for previous mental illness.
  • ICU stay less than 24 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SIR
All adult intensive care patients. Data from the The Swedish intensive care registry
Invasive ventilation more than 24hs.
Other Names:
  • CRRT
  • Invasive ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental illness
Time Frame: 2010-2015
Defined as PTSD, depressive symptoms or anxiety or combination of the earlier mentioned.
2010-2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

December 31, 2015

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

November 16, 2021

First Posted (Actual)

November 30, 2021

Study Record Updates

Last Update Posted (Actual)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • RBM2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Intensive Care

Subscribe