NCT04601090

Brief Summary

The study 'Survival rates and long-term outcomes for patients with COVID-19 admitted to Norwegian ICUs' is a national observational study, including patients admitted to a Norwegian ICU between March 2020 and March 2021. The study will describe survival rates, clinical characteristics and health challenges experienced by survivors the first year after ICU admission caused by COVID-19 disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
860

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

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

September 16, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 23, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2022

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

October 15, 2020

Last Update Submit

July 14, 2022

Conditions

Keywords

ICU treatment

Outcome Measures

Primary Outcomes (2)

  • ICU Survival rate

    Time to survival

    up to 30 days

  • Change in Functional Status

    Measured by self-reporting using Lawton Instrumental activity of daily living. Higher score indicates better function, and ranges from 0-8.

    6 and 12 months after ICU admission

Secondary Outcomes (3)

  • Change in Anxiety and Depression

    Measured 6 and 12 months after ICU admission

  • Changes in Cognitive Status

    Measured at 6 and 12 months after ICU admission

  • Change in Quality of Life 6 and 12 months after ICU admission

    Measured 6 and 12 months after ICU admission

Interventions

This is an observational study, so all patients will undergo a variation of ICU treatment, and we will record that information (e.g., time on ventilator, time in ICU, SAPS score at admission)

Eligibility Criteria

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

All patients that have been admitted to a Norwegian ICU with confirmed COVID-19, and not reserved them against the national register, will be contacted for inclusion to the study.

You may qualify if:

  • Patients registered in Norwegian Intensive Care Register, that are ≥ 18 years with confirmed cases of COVID-19.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0027, Norway

Location

Related Publications (1)

  • Laake JH, Hagen M, Aavitsland P, Buanes EA, Fjone KS, Kvale R, Olsen BF, Hofso K. COVID-19 in Norwegian ICUs 2020-2023: Patient characteristics, management, and outcomes-A nationwide prospective observational study. Acta Anaesthesiol Scand. 2025 Apr;69(4):e70027. doi: 10.1111/aas.70027.

MeSH Terms

Conditions

COVID-19Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Kristin Hofsø, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 23, 2020

Study Start

September 16, 2020

Primary Completion

June 30, 2021

Study Completion

July 10, 2022

Last Updated

July 15, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations