Effect Of Acute Inflammatory Mediators On Functional Limitations In Patients With Acute Respiratory Failure

NCT ID: NCT01707303

Last Updated: 2018-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-08-31

Brief Summary

This is a randomized, controlled, pilot study of two separate Cohorts of patients from the intensive care unit. Cohort I will enroll 50 patients and randomize to receive one physical therapy session per day or receive usual ICU care. Cohort II, will enroll an additional 50 patients and randomize to receive either two physical therapy sessions per day or usual care. Outcome will be length of hospital stay measured in days. Secondary outcomes will be mortality, ventilator days, ICU days, and for Cohort II, grip strength, dynamometer strength assessments and the short physical performance battery (SPPB). Study subjects will have blood for cytokine analysis through their first week of study.

Conditions

Acute Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual Care

Usual hospital rehabilitative services

Group Type: OTHER

Usual Care

Intervention Type: OTHER

All typically applied hospital rehabilitative services applied in the usual fashion

Early ICU Rehabilitation Strategy

Early ICU physical therapy will be applied in this arm

Group Type: EXPERIMENTAL

Early ICU rehabilitation strategies

Intervention Type: OTHER

Physical therapy - standard; Physical therapy, progressive resistance training for 2nd physical therapy session in Cohort II

Interventions

Early ICU rehabilitation strategies

Physical therapy - standard; Physical therapy, progressive resistance training for 2nd physical therapy session in Cohort II

Intervention Type: OTHER

Usual Care

All typically applied hospital rehabilitative services applied in the usual fashion

Intervention Type: OTHER

Other Intervention Names

Cohort I will receive one physical therapy session per day; Cohort II will receive 2 physical therapy sessions per day.; Usual Hospital Rehabilitative Services

Eligibility Criteria

Inclusion Criteria

• Mechanically ventilated via an endotracheal tube or mask

Exclusion Criteria

• Inability to walk without assistance prior to acute ICU illness (use of a cane or walkers not exclusions)
• Cognitive impairment prior to acute ICU illness (non-verbal)
• Preadmit immunocompromised (>prednisone 20 mg/d for 2 wks)
• Acute stroke
• Body mass index (BMI) >45
• Neuromuscular disease that could impair weaning (myasthenia gravis, ALS, Guillain-Barre)
• Hip fracture, unstable cervical spine or pathological fracture
• Mech vent >48 hours prior to transfer from an outside facility
• Current hospitalization or transferring hospital stay >72 hours
• CPR on admission, DNR on admission
• Hospitalization within 30 days prior to admission
• Cancer therapy within last 6 months
• Re-admission to ICU within current hospitalization

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter E. Morris, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00000240

Identifier Type: -

Identifier Source: org_study_id