Fatigue One Year After ICU Discharge

April 28, 2016 updated by: Savino Spadaro, Università degli Studi di Ferrara

Fatigue in Intensive Care Survivors One Year After Discharge

The investigators contacted consecutive adult patients admitted to intensive care unit (ICU) and mechanically ventilated for at least 72 hours to invite them to an interview at hospital. The investigators administered Mini Mental Status Examination, Functional Assessment of Chronic Illness Therapy scale for Fatigue (Facit- F) and Short form 36 questionnaires to the consenting patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fatigue is one of the most commonly symptoms reported by patients. There are many causes of pathological fatigue including mental and physical, both neurological (central and peripheral) and non-neurological diseases. Among the last ones, cancer, infections and drugs are factors associated with fatigue, although the mechanism of how non-neurological diseases cause fatigue is not clear. Evidence exists to suggest that patients who have been critically ill continue to face a multitude of physical, psychological and social difficulties in the long term after discharge. As far as fatigue is concerned, greater than 50% of Intensive Care Unit survivors overall reported lowered energy levels and fatigue in the first year after discharge.

Study Type

Observational

Enrollment (Actual)

56

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Intensive care one-year survivors

Description

Inclusion Criteria:

  • aged > 18 years
  • able to co-operate at the time of ICU discharge
  • requiring mechanical ventilation for at least 72 hours
  • residents less than 30 km from the hospital

Exclusion Criteria:

  • preexisting cognitive deficits
  • pre-existing psychotic illness
  • admitted for anoxic brain injury
  • residents more than 30 km from the hospital

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intensive care survivors
Observational study
Other: Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Short form 36 questionnaire
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Ferrara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

February 13, 2016

First Submitted That Met QC Criteria

February 17, 2016

First Posted (Estimate)

February 18, 2016

Study Record Updates

Last Update Posted (Estimate)

May 2, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fatigue

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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