- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05137977
Is Invasive ICU-treatment Associated With Mental Illness?
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years old
Exclusion Criteria:
- ICD codes for previous mental illness.
- ICU stay less than 24 hours
Study Plan
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBM2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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