Liver Failure Clinical Trial
Official title:
Early Cycle Ergometry for Critically-Ill Liver Failure Patients in a Transplant Intensive Care Unit
Verified date | March 2024 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Critically-ill patients with liver disease are at high risk of developing sarcopenia and intensive care unit (ICU)-acquired weakness, which are associated with mortality and other poor outcomes. Early physical rehabilitation has shown benefit in ICU settings, but has not been studied in ICU patients with acute and chronic liver failure. Cycle ergometry, or stationary cycling in passive and active modes, may be especially beneficial to such patients due to their high prevalence of severe physical deconditioning and variable mentation. The aim of this study is to examine the feasibility, safety, and benefit of cycle ergometry over standard physical and occupational therapy (PT/OT) in critically-ill patients who have acute or chronic liver disease.
Status | Terminated |
Enrollment | 97 |
Est. completion date | September 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults 18 = years with acute or chronic liver disease admitted to Transplant Intensive Care Unit (TICU), or admitted to TICU following a liver or liver-kidney transplant - Expected to remain in ICU for = 5 days - Spoken English fluency Exclusion Criteria: - Known primary systemic neuromuscular disease or intracranial process causing increased intracranial pressure - Lower extremity amputation - Anticipated death or palliative withdrawal of life support within 5 days - Cycle ergometer weight limit (135 kg or 297.6 lbs per manufacturer) |
Country | Name | City | State |
---|---|---|---|
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional Status Score for the Intensive Care Unit (FSS-ICU) | Standardized assessment tool for functional status in ICU patients. Score ranges from 0 (unable to perform) to 35 (highest function). | Through study completion, average of 1 year | |
Secondary | Number of participants who experience an adverse event during therapy | Total number of participants who experience an adverse event during PT/OT and cycling sessions during course of study | Through study completion, average of 1 year | |
Secondary | Duration of mechanical ventilation | Average number of days on mechanical ventilation | Through study completion, average of 1 year | |
Secondary | ICU length of stay | Average length of stay in days | Through study completion, average of 1 year | |
Secondary | Number of participants who experience ICU readmission | Total number of participants readmitted to ICU during study period | Through study completion, average of 1 year |
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