Respiratory Failure
Conditions
Keywords
ICU, Respiratory Failure, Weakness, Nitrate supplementation
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
Interventions
DIETARY_SUPPLEMENTPlacebo
DIETARY_SUPPLEMENTNitrate Rich Beetroot Juice
Nitrate rich beetroot juice diet supplement will be consumed by subjects.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
56 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| physical function assessed using the Short Physical Performance Battery (SPPB) | 2 months | The SPPB is based on timed measures of standing balance, walking speed, and ability to rise from a chair. Each performance measure is assigned a score ranging from 0 to 4, with 4 indicating the highest level of performance and 0 inability to complete the test. A summary score (range 0-12) will be calculated by adding the three scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Nitrate and Nitrite Levels | 5 days | Blood samples will be collected in 4 mL lithium heparin vials. Nitrate and nitrite will be measured separately using the ENO-20 NOx analyzer. |
| Skeletal muscle strength | 2 months | Skeletal muscle strength will be measured in both upper and lower extremities. Hand grip strength in both hands will be measured using a hand held grip strength dynamometer. Additionally, an electronic strength dynamometer will be used to collect strength measures of the elbow flexion, elbow extension, shoulder flexion in the scaption plane, ankle dorsiflexion, knee extension and hip extension, bilaterally. Skeletal muscle ultrasound will be performed on upper and lower extremities bilaterally. |
| Hospital Length of Stay | 2 weeks | The hospital calendar days (or any portion of a calendar day) at the enrolling hospital and at any long term acute care facility to which the subject is directly transferred. |
Countries
United States
Outcome results
None listed