Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05137977 |
| Other study ID # |
RBM2021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2010 |
| Est. completion date |
December 31, 2015 |
Study information
| Verified date |
November 2021 |
| Source |
Uppsala University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
