Early Cycle Ergometry for Critically-Ill Liver Failure Patients in a Transplant Intensive Care Unit

Liver Failure Clinical Trial

Official title:

Early Cycle Ergometry for Critically-Ill Liver Failure Patients in a Transplant Intensive Care Unit

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04160039
• Other study ID #: PRO32773
• Status: Terminated
• Phase: N/A
• Start date: November 10, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: March 2024
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

A single-blinded randomized controlled trial will be conducted in a transplant intensive care unit (TICU). Eligible adult patients will be enrolled within 72 hrs after TICU admission and randomly allocated to either (1) standard PT/OT care, or (2) PT/OT care and cycle ergometry sessions with trained PT/OT therapists or technicians. The outcome measures, tests of strength and function, will be assessed at baseline, every 14 days, and upon TICU discharge by a blinded PT/OT therapist.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Hepatic Insufficiency
• ICU Acquired Weakness
• Liver Cirrhoses
• Liver Cirrhosis
• Liver Failure

Intervention

Device:
• Cycle ergometry
Lower extremity cycle ergometry, passive and/or active, up to 20 minutes per session, up to 5 sessions per week

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

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