Clinical trial NCT04160039: Early Cycle Ergometry for Critically-Ill Liver Failure Patients in a Transplant Intensive Care Unit
Official title: Early Cycle Ergometry for Critically-Ill Liver Failure Patients in a Transplant Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Cirrhoses
Liver Failure
ICU Acquired Weakness
Keywords: Cycle Ergometry
Physical Therapy
Rehabilitation
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Functional Status Score for the Intensive Care Unit (FSS-ICU)
timeFrame: Through study completion, average of 1 year
Secondary outcomes:
measure: Number of participants who experience an adverse event during therapy
timeFrame: Through study completion, average of 1 year
measure: Duration of mechanical ventilation
timeFrame: Through study completion, average of 1 year
measure: ICU length of stay
timeFrame: Through study completion, average of 1 year
measure: Number of participants who experience ICU readmission
timeFrame: Through study completion, average of 1 year
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Priyal Patel, MD
role: PRINCIPAL_INVESTIGATOR
References: