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OpenTrials
Completed

NCT Number: NCT02684877

Fatigue One Year After ICU 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.

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Key information

Conditions

Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

Primary outcomes

  1. Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F)

    Time frame: 12 months

Secondary outcomes

  1. Short form 36 questionnaire

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Registry information

Official study title

Fatigue in Intensive Care Survivors One Year After Discharge

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 18, 2016
Registry last updated
May 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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