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

Acute Respiratory Distress Syndrome Clinical Trial

— PRIMROSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03038906
• Other study ID #: PRIMROSE
• Status: Recruiting
• Phase: N/A
• First received: January 9, 2017
• Last updated: January 29, 2017
• Start date: January 2017
• Est. completion date: September 2020

Study information

• Verified date: January 2017
• Source: University of Washington
• Contact: Catherine Hough, MD
• Phone: 2067443356
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: September 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Neuromuscular Diseases
• Neuromyopathies
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuromyopathy	The investigators are assessing neuromyopathy with electrophysiologic testing	Through 6 months after hospital discharge
Primary	Muscle Function and Strength	The investigators are assessing muscle strength with handgrip and handheld dynamometry	Through 6 months after hospital discharge
Primary	Physical Recovery and Healthcare Utilization	The investigators are assessing physical recovery with the short physical performance battery	6 months post ARDS