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Impact of NMES and HPRO on Recovery After SAH- Pilot Study

RecruitingNAAges 18 Years - anyAllUniversity of Maryland, Baltimore
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In plain words

What the trial is, and whether it could suit you

The study purpose is to investigate the hypothesis that in adults with SAH, early neuromuscular electrical stimulation (NMES) and high protein supplementation (HPRO) will improve muscle mass, metabolic and inflammatory biomarker profiles, compared to SAH controls receiving standard of care interventions for nutrition and mobilization. The investigators will accomplish this by studying the effects of a high protein (HPRO) nutritional treatment as well as NMES intervention have upon muscle wasting and motor strength acutely after SAH. This will be addressed in a prospective trial of SAH patients receiving HRPO with NMES as compared to age and severity-matched SAH patients undergoing standard of care interventions for nutrition and mobilization. Additionally, the study will investigate the impact HPRO and NMES interventions have upon inflammatory cytokines and markers of energy balance. Res

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: 1. . Being diagnosed with aneurysmal SAH 2. . Aneurysmal repair within 48 hours of ictus. 3. . Age between 25 and 80 years old. (\>=25 years old and \<=80 years old) 4. . Expected stay in the NCCU \> 72 hours. 5. . Admission Hunt Hess Grade \>=2. 6. modified Fisher score \>1. Exclusion criteria: 1. . Subjects diagnosed with SAH from trauma, rupture of an arteriovenous malformation, neoplasm, vasculitis, or other secondary causes; 2. . Unlikely to survive one week post hemorrhage either due to impending brain death or likely request for withdrawal of care; 3. . Unlikely to remain in the ICU for more than 7 days; 4. . Body mass index \< 15 or \>40 kg/m2; 5. . Allergy to whey protein; 6. . Evidence of lower extremity paresis or spasticity within 48 hours of injury 7. . Pre-morbid modified Rankin Score \>1. 8. . Known pregnancy 9. . Presence of active malignancy 10. . Diagnosis of an inflammatory disorder 11. . Presence of a neuromuscular disorder 12. . Diagnosis of chronic renal insufficiency or acute kidney injury (GFR \< 30 mL/min/1.73m2) 13. . Hepatic insufficiency defined as AST/ALT levels \>2.5 above normal upper limits. 14. . On-going seizure activity as assessed clinically or by electrographic detection on continuous electroencephalogram (cEEG) at time of enrollment 15. . Prisoner.
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What it tests

  • Neuromuscular Electrical Stimulation (NMES)
  • High Protein Supplementation
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Where

1 site
University of Maryland Medical Center
Baltimore, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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