Effect of Randomization to Neuromuscular Blockade on Physical Functional Impairment and Recovery in ARDS

NCT03038906 | Unknown

• 1 other identifier: PRIMROSE
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed work will determine the effect of neuromuscular blockade on physical function and recovery in patients with ARDS. The investigators will conduct a prospective ancillary study at five PETAL clinical centers that will evaluate the neuromuscular structure and function of ROSE (Reevaluation of Systemic Early Neuromuscular Blockade) patients during and after critical illness, including in-person assessments at 6 months after hospital discharge. The investigators hypothesize that patients randomized to NMB will have an increase in ICU-acquired neuromuscular dysfunction during and after critical illness.

Conditions

Acute Respiratory Distress Syndrome; Neuromyopathies

Outcome Measures

Primary Outcomes (3)

• Neuromyopathy

  The investigators are assessing neuromyopathy with electrophysiologic testing

  Through 6 months after hospital discharge

• Muscle Function and Strength

  The investigators are assessing muscle strength with handgrip and handheld dynamometry

  Through 6 months after hospital discharge

• Physical Recovery and Healthcare Utilization

  The investigators are assessing physical recovery with the short physical performance battery

  6 months post ARDS

Study Arms (1)

Cohort

Patients enrolling in NHLBI PETAL Network ROSE study of cisatracurium for moderate/severe ARDS at participating centers

Eligibility Criteria

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

Study Population

Subjects enrolled in the PETAL Network's ROSE (Reevaluation of Systemic Early Neuromuscular Blockade) Study.

You may qualify if:

• Patients must be enrolled in the PETAL Network's ROSE study
• Patients must have at least one complete leg

You may not qualify if:

• Complete spinal cord injury with deficits at level T1 or above
• Severe peripheral neuromuscular disease (specifically motor neuron disease (ALS) or acute Guillain-Barre Syndrome)
• Inability to obtain informed consent

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Nervous System Diseases

Study Officials

• Catherine Hough, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Hough, MD

CONTACT

2067443356

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: February 1, 2017
• Study Start: January 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: September 1, 2020
• Last Updated: February 1, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)