Strength Testing After Nitrate Delivery (STAND) in ICU Patients
Completed · Not applicable · Has a placebo group
Conditions studied: Respiratory Failure
In brief
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.
Key facts
- Study ID
- NCT02293616
- Run by
- Wake Forest University Health Sciences
- People needed
- 25
- Starts
- 2015-06-01
- Expected to finish
- 2017-04-01
- Last updated by the study team
- 2018-07-18
Who can join
Age: 56 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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