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Prognostication of Need for Rehabilitation and Special Support in ICU Survivors

NCT02679157 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 573

Last updated 2018-02-13

No results posted yet for this study

Summary

Title: PROGnostication of need for REhabilitation and Special Support after Intensive Care Unit Stay - a multinational, observational study

Objectives:

1. To investigate associations between potential risk factors (premorbid factors, in-ICU treatments/diagnoses and patient status at ICU discharge) and three-month physical and psychological outcome in ICU survivors.
2. Based on the associations between identified risk factors and adverse outcomes, create and validate instruments, to be used at ICU discharge, predicting new-onset physical or psychological problems three months after ICU discharge.

Study design:

Prospective, observational multi centre (10 centres) cohort studies

Outcomes:

Adverse psychological outcome three months after ICU discharge (Posttraumatic Stress Syndrome-14 (PTSS-14) part B score \>45 or Hospital Anxiety and Depression Scale (HADS) subscale score \>10). New-onset physical disability, defined as a reduction in Barthel Index ≥10 points compared with 2 weeks prior to hospital admission.

Study duration:

Recruitment of patients during 2-4 months in the ten study sites. Follow-up of primary endpoints 3 months after ICU discharge.

Number of subjects:

The aim is to screen all eligible patients and include 600-1000 ICU survivors during the recruitment period. The final number of included patients depends on case-mix in the units and potential exclusions.

Population:

Adult patients (18 years or older) discharged from ICU.

Conditions

Sponsors & Collaborators

  • Region Stockholm

    collaborator OTHER_GOV

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Peter V Sackey, MD, PhD · Karolinska University Hospital

  • Anna Milton, MD · Karolinska University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Denmark
  • Netherlands
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02679157 on ClinicalTrials.gov