NCT05137977

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,048,576

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

6 years

First QC Date

November 16, 2021

Last Update Submit

November 16, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mental illness

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

    2010-2015

Study Arms (1)

SIR

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

Procedure: Intensive Care

Interventions

Invasive ventilation more than 24hs.

Also known as: CRRT, Invasive ventilation
SIR

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Nationwide registry of patients admitted to ICU treatment in Sweden.

You may qualify if:

  • years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

postintensive care syndromeAnxiety DisordersDepressionStress Disorders, Post-Traumatic

Interventions

Critical CareNoninvasive Ventilation

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesRespiration, ArtificialAirway ManagementRespiratory Therapy

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

November 30, 2021

Study Start

January 1, 2010

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

November 30, 2021

Record last verified: 2021-11