Inflammation, Muscle Atrophy, Nutritional and Metabolic Disease, Subarachnoid Hemorrhage
Conditions
Brief summary
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. Results of this study will establish evidence for precision nutrition plus early exercise to mitigate the catabolic and inflammatory state produced by SAH to improve muscle, metabolic, and health recovery outcomes.
Interventions
DEVICENeuromuscular Electrical Stimulation (NMES)
Neuromuscular electrical stimulation twice daily during study period.
DIETARY_SUPPLEMENTHigh Protein Supplementation
High protein supplementation with whey protein shakes taken three times a day during study period.
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle layer thickness of the quadriceps muscle as measured by muscle ultrasound scan at the end of study period. | 14 days | Change in the muscle layer thickness of the quadriceps muscle as measured by ultrasound. |
Countries
United States
Contacts
CONTACTNeeraj Badjatia, MD MSc
PRINCIPAL_INVESTIGATORNeeraj Badjatia, MD MSc
University of Maryland, Baltimore
Outcome results
None listed