None listed
Conditions
Interventions
Dietary Supplement : Patients will be systematically allocated in a 1:1 ratio to receive high protein EN or standard EN. The ready-to-use control and standard EN products have identical packaging with
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years and = 85 years 2. Acute stroke (hemorrhagic) patients including subarachnoid hemorrhage (SAH) d/t aneurysm rupture, arterio-venous malformation (AVM) or cavernous malformation (CM) rupture, (hypertensive) intracranial or intraventricular hemorrhage (ICH or IVH), or cerebral infarct 3. Acute traumatic brain injury ?epidural hematoma (EDH), subdural hematoma (SDH), subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), intraventricular hemorrhage (IVH), diffuse axonal injury, concussion? 4. Glasgow coma score (GCS): 6 ~ 12 5. Expected ICU stay > 72 hours and in need of enteral nutrition for at least 7 days by clinical evaluation
Exclusion criteria
Exclusion criteria: 1. At high nutritional risk (Nutritional Risk Screening 2002 version = 5) 2. Current total parenteral nutrition (TPN) use 3. Unstable vital signs requiring the use of vasoactive agents or any other clinical situations where enteral feeding cannot initiate. 4. Concomitant medical illness that may interfere with the study outcome assessments and/or follow up 1.1 Hemodialysis, AKI, CKI or any clinical evidence (e.g., high serum BUN level) that may need protein restriction 2.2 Disease that may associated with muscle atrophy or weakness (Duchenne muscular atrophy, ALS, etc.) 3.3 Systemic malignant tumor (brain, lung, gastric, colon, liver, breast and etc.) 4.4 Liver cirrhosis – Child’s class C liver disease 5.5 Hematologic disease ?acute myeloid leukemia, acute lymphocytic leukemia or other disease-causing thrombocytopenia ( 2 INR)?. 6.6 Post-anoxic coma; status epilepticus without underlying brain injury; central nervous system (CNS) infections (community-acquired; hospital-acquired; ventriculitis; post-operative) 5. History of neurological disease, causing significant cognitive and/or motor strength deficit (mRS 3-5) 6. History of gastrectomy or enterectomy 7. Pregnancy 8. GCS < 6; brain death or imminent death (within 72 hours) 9. DNR (do not resuscitate) ordered patient 10. Currently participating in other investigational trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ICU mobility scale | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Muscle mass and skeletal muscle index (SMI) SMI is defined as appendicular muscle mass, assessed using BIA (Physion MD, Nippon Shooter Ltd., Tokyo, Japan), divided by height squared (kg/m2);Nutritional status assessed by blood laboratory samples: albumin, pre-albumin, transferrin, hemoglobin, total cholesterol, iron, urea nitrogen;Glasgow Coma scale ;mRS (modified Rankin Scale) ;Mechanical ventilator application (days) ;The length of hospital and ICU stay (days);Metabolic intolerance (hyper/hypo glycemia, hyper/hypo natremia, hyper/hypo kalemia) | — |
Countries
Korea, Republic of
Contacts
Public ContactMoinay Kim
Asan Medical Center
Outcome results
None listed