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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Respiratory Distress Syndrome; Neuromyopathies

Detailed Description

The investigators will assess this dysfunction in different ways, appropriate for patients' stage of critical illness and anticipated recovery. During critical illness, the investigators will use nerve conduction studies (NCS) to assess nerve and muscle function, identifying presence of early neuromyopathy (primary outcome, Aim 1). Additional early assessments will include bedside ultrasound to determine muscle mass and echogenicity, indices of atrophy and loss of muscle architecture. Later in acute hospitalization as patients are able to participate in testing, the investigators will use hand grip dynamometry to assess muscle strength (primary outcome, Aim 2). Additional assessments at this time will be hand held dynamometry to determine proximal muscle strength, dual energy x-ray absorptiometry (DEXA) and repeat ultrasound to evaluate muscle mass, and short physical performance battery (SPPB) to assess activity. After hospital discharge-at 6 months after ARDS-the investigators will assess activity in-person using the SPPB (primary outcome, Aim 3). Additional post-hospital assessments include detailed evaluation of healthcare utilization, six minute walk testing (6MWT) to determine endurance, and repetition of previous assessments of muscle structure, function and strength to provide novel, detailed information of recovery process.

Each aim tests a distinct hypothesis of the effect of randomization to NMB on ICU-acquired neuromuscular dysfunction, investigating different time points and aspects of physical function, so aims are not interdependent. For example, it is plausible that the direct toxicity of NMB on muscle will lead to early evidence of neuromyopathy, manifest as reduced muscle depolarization amplitudes with nerve stimulation. But if NMB attenuates lung injury, strength may be improved by hospital discharge, despite early injury to muscle.

• Study Type: Observational
• Enrollment (Anticipated): 290

Contacts and Locations

• Study Contact: Name: Catherine Hough, MD; Phone Number: 2067443356

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • University of Washington
      • Contact: Stephanie Gundel, RD; Phone Number: 206-744-7720; Email: sgundel@uw.edu
      • Principal Investigator: Catherine L Hough, MD, MSc
      • Principal Investigator: Theodore J Iwashyna, MD, PhD
      • Principal Investigator: Daniel C Files, MD
      • Principal Investigator: Peter C Hou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Catherine Hough, MD, University of Washington

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: January 9, 2017
• First Submitted That Met QC Criteria: January 29, 2017
• First Posted (Estimate): February 1, 2017

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 29, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: PRIMROSE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No