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

NCT01707303 | Completed DMC

• 1 other identifier: IRB00000240
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

ICU; Critical Care; Intensive Care; Critical Illness; Acute Respiratory Failure; Mechanical Ventilation; Physical Therapy; Strength; Functional Status; Short Physical Performance Battery

Outcome Measures

Primary Outcomes (1)

• Hospital length of stay, days

  Hospital stay measured in days.

  The participants will be followed for the duration of the hospitalization, an expected average of 3 weeks.

Study Arms (2)

Usual Care

OTHER

Usual hospital rehabilitative services

Other: Usual Care

Early ICU Rehabilitation Strategy

EXPERIMENTAL

Early ICU physical therapy will be applied in this arm

Other: Early ICU rehabilitation strategies

Interventions

Early ICU rehabilitation strategies OTHER

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

Also known as: Cohort I will receive one physical therapy session per day; Cohort II will receive 2 physical therapy sessions per day.

Early ICU Rehabilitation Strategy

Usual Care OTHER

All typically applied hospital rehabilitative services applied in the usual fashion

Also known as: Usual Hospital Rehabilitative Services

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mechanically ventilated via an endotracheal tube or mask

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter E. Morris, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: October 16, 2012
• Study Start: July 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 15, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)