Clinical trial NCT02293616: Strength Testing After Nitrate Delivery (STAND) in ICU Patients
Official title: Strength Testing After Nitrate Delivery (STAND) in ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: ICU
Respiratory Failure
Weakness
Nitrate supplementation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2014-11-18
Enrollment: 25
Sex: ALL
Minimum age (years): 56
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is well documented that intensive care unit (ICU) patients have lower levels of skeletal muscle strength compared to non-ICU patients upon hospital discharge, and this weakness affects the patient's ability to perform basic activities of daily living upon hospital discharge and for extended periods thereafter. Recently, critically ill ICU patients have been shown to have lower nitric oxide levels. These patients often suffer from a disturbed homeostasis with circulatory and metabolic abnormalities that may potentially contribute to their ICU acquired weakness. Given the recent research showing dietary nitrate supplementation can increase nitric oxide levels and improve exercise tolerance in healthy and diseased older individuals, our aim is to investigate the importance of nitrate supplementation in ICU patients with focus on physical function and ICU acquired muscle weakness.

Detailed description: The proposed study is an investigator initiated, double blind, placebo controlled experimental study designed to evaluate the effect of chronic NO3- supplementation via beetroot juice ingestion on the skeletal muscle strength and physical function in ICU patients. Patients will be randomized to receive either nitrate rich or nitrate depleted beetroot juice once daily during their ICU and hospital stay. Physical function and skeletal muscle strength will be measured at ICU (± 2 days) and hospital (± 2 days) discharge and 2 months (± 2 weeks) after enrollment. Plasma levels of nitrate and nitrite will be measured 1, 3 and 5 days after randomization into the trial and at ICU and hospital discharge. Skeletal muscle ultrasound will be performed to examine the size and echogenicity of patient muscles. Self-reported physical function will be measured using the Functional Performance Inventory Short Form (FPI-SF). The FPI-SF provides an overall score of patient self-reported functional performance in the areas of household maintenance, movement, family and social activities, work, avocation and recreation

Eligibility criteria: Inclusion Criteria:

* Age \> 55 years
* Mechanically ventilated via an endotracheal tube or mask who have begun spontaneous breathing trials or extubated within the previous 24 hours
* Lung Injury as defined by a PaO2 / FiO2 \< 300

Exclusion Criteria:

* Inability to walk without assistance prior to acute ICU illness (use of a cane or walkers not exclusions)
* Cognitive impairment prior to acute ICU illness (non-verbal)
* Acute stroke
* Body mass index (BMI) \>50
* Neuromuscular disease that could impair weaning (myasthenia gravis, ALS, Guillain-Barre)
* Hip fracture, unstable cervical spine or pathological fracture
* Mechanically Ventilated \> 80 hours
* Current hospitalization or transferring hospital stay \> 7 days
* DNR/DNI on admission
* Cancer treatment within the last 6 months
* Moribund
* Participation in another research study
* On nitroglycerine or nitrate preparations used with angina or phosphodiesterase type 5 inhibitors
* Body mass less than 60 kg

Primary outcomes:
measure: physical function assessed using the Short Physical Performance Battery (SPPB)
timeFrame: 2 months
Secondary outcomes:
measure: Plasma Nitrate and Nitrite Levels
timeFrame: 5 days
measure: Skeletal muscle strength
timeFrame: 2 months
measure: Hospital Length of Stay
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: D. Clark Files, MD
role: PRINCIPAL_INVESTIGATOR
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