Recruiting

Neuromuscular Blockade

Sponsor:

University of Washington

Code:

NCT03038906

Conditions

Acute Respiratory Distress Syndrome

Neuromyopathies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT03038906

Start date

Jan, 2017

Status verified date

Jan, 2017

Completion date

Sep, 2020

Anticipated

Primary completion date

Mar, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

290 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort

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

Primary outcome measure

  • Neuromyopathy [ Time Frame: Through 6 months after hospital discharge ]
  • Muscle Function and Strength [ Time Frame: Through 6 months after hospital discharge ]
  • Physical Recovery and Healthcare Utilization [ Time Frame: 6 months post ARDS ]

Central Contacts and Locations

Central contacts

Catherine Hough, MD

2067443356

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98104

Contacts

Stephanie Gundel, RD

206-744-7720sgundel@uw.edu

Principal Investigator:

Catherine L Hough, MD, MSc

More Information

Sponsor

University of Washington

Last update posted

Feb 1, 2017

Last verified

Jan, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by University of Washington on 2017-02-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.