ABC + Post-Intensive Care Study Draft V 1.1 10.06.2021
Research type
Research Study
Full title
Anaemia & functional capacity, fatigue, daily activity, sleep and Circadian Rhythm Disruption among critical illness survivors
IRAS ID
286272
Contact name
Timothy Walsh
Contact email
Sponsor organisation
The University of Edinburgh
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
With the advance of medical science and technology more and more critically ill patients survive. However, the majority of survivors have unwanted health-related issues for a long time after.
Generally, individuals after a serious illness who were treated in the Intensive Care Unit (ICU) have both low haemoglobin concentration (anaemia) and impaired physical capabilities with markedly retarded natural restoration pace. This adversely affects the individuals’ quality of life.
Recently in the UK, a multicentred clinical trial (ABC post-ICU trial) has begun, aiming to investigate the possible positive effects of the rapid anaemia correction by blood transfusion among critical illness survivors. As a side study to this trial at the single site (The Royal Infirmary Edinburgh), we plan to investigate the way how a different blood haemoglobin content (anaemia grade) affects exercise capacity, sedentary behaviour, quality of sleep, feeling of fatigue, and activities of daily living in patients after critical illness. Also, the feasibility of early bicycle-based cardiopulmonary capacity testing in hospitalized critical care survivors will be investigated.
We plan to recruit adults with capacity who have been successfully discharged from the ICU. The participants will be divided into three groups. The first, feasibility group is designed to include participants after a more severe illness, those who have been receiving mechanical lung ventilation no less than 72 hours. The second and the third group will include participants from both arms of the ABC post-ICU trial, control, and intervention.
Within the framework of the study, participants will be asked to fill in paper-based questionnaires regarding their feeling of fatigue and the activity of daily living two times, to wear a wrist-worn accelerometer device for as long as they can during day and night for approximately two months, even after hospital discharge. But, they could take it off whenever they want. And finally, close to the hospital discharge (10-20 days after ICU) participants will undertake a bicycle-based cardiopulmonary exercise test.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
21/ES/0051
Date of REC Opinion
25 Jun 2021
REC opinion
Further Information Favourable Opinion