Strength Testing After Nitrate Delivery (STAND) in ICU Patients
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 56 - Any |
| Updated: | 7/20/2018 |
| Start Date: | June 2015 |
| End Date: | April 2017 |
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.
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.
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
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
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
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: D Clark Files, MD
Phone: 336-716-8898
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