NCT04247607

Brief Summary

This prospective observational study aims to describe the outcome for patients with persistent or chronic critical illness treated at Remeo, a clinic specialized for patients in need of prolonged intensive care and intensive care rehabilitation in Sweden. Patients' disease characteristics and the treatment in multidisciplinary patient centered teams for intensive care, weaning from mechanical ventilation and simultaneous rehabilitation will be described. Patients will be followed one year after discharge to document health related quality of life, physical function, frailty, mental illness and used health care resources.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 13, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 2, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

4 years

First QC Date

January 2, 2020

Last Update Submit

November 4, 2022

Conditions

Critical Illness

Keywords

persistent critical illnesschronic critical illnessprolonged intensive careweaning from mechanical ventilationdecannulationmultidisciplinary teamintensive care rehabilitation

Outcome Measures

Primary Outcomes (15)

  • Change in mechanical ventilation status

    Time (Days) from admittance to unit until weaned from mechanical ventilation

    Assessed at admittance and immediately after discharge from unit

  • Change in tracheostomy status

    Time (Days) from admittance to unit until decannulation

    Assessed at admittance and immediately after discharge from unit

  • In-patient mortality and mortality

    Mortality during care at unit

    Assessed immediately after discharge from unit

  • Mortality during 12 months follow-up after discharge

    Mortality during 12 months follow-up after discharge

    Assessed 12 months after discharge

  • Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36)

    RAND36 (scale 0-100, higher value better) questionnaire

    3 months after discharge from unit

  • Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36)

    RAND36 (scale 0-100, higher value better) questionnaire

    6 months after discharge from unit

  • Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36)

    RAND36 (scale 0-100, higher value better) questionnaire

    12 months after discharge from unit

  • Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L)

    EQ-5D-5L questionnaire

    3 months after discharge from unit

  • Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L)

    EQ-5D-5L questionnaire

    6 months after discharge from unit

  • Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L)

    EQ-5D-5L questionnaire

    12 months after discharge from unit

  • Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)

    Katz ADL (scale 0-6, higher value better)

    At admission to unit

  • Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)

    Katz ADL (scale 0-6, higher value better)

    Immediately before decannulation

  • Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)

    Katz ADL (scale 0-6, higher value better)

    Immediately before discharge from unit

  • Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)

    Katz ADL (scale 0-6, higher value better)

    6 months after discharge from unit

  • Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)

    Katz ADL (scale 0-6, higher value better)

    12 months after discharge from unit

Secondary Outcomes (29)

  • Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)

    3 months after discharge from unit

  • Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)

    6 months after discharge from unit

  • Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)

    12 months after discharge from unit

  • Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire

    3 months after discharge from unit

  • Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire

    6 months after discharge

  • +24 more secondary outcomes

Other Outcomes (5)

  • Antibiotic use

    From admittance until discharge

  • Antibiotic use 12 months after discharge

    From discharge until12 month thereafter

  • Discharge destination

    Immediately after discharge from unit

  • +2 more other outcomes

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with prolonged critical illness treated at the specialized unit (Remeo, Stockholm, Sweden)

You may qualify if:

  • Admission to unit (Remeo, Stockholm, Sweden) Treated for prolonged critical illness

You may not qualify if:

  • Treated less than 48 hours at unit (Remeo, Stockholm, Sweden)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Remeo

Sköndal, Stockholm County, 12864, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eva Sundman, MD, PhD

    Remeo and Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Sundman, MD, PhD

CONTACT

+46702086783eva.sundman@remeo.se

Anna Cedborg, MD, PhD

CONTACT

+46709564216anna.cedborg@remeo.se

Study Design

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

Study Record Dates

First Submitted

January 2, 2020

First Posted

January 30, 2020

Study Start

December 13, 2019

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)