High-Protein Diet (Enteral Feeding) in the Acute Brain Hemorrhage Patients to Prevent Sarcopenia: A Prospective Multicenter Randomized Blinded Study

Asan Medical Center0 个研究点目标入组 230 人开始时间: 待定最近更新: 2024年8月19日

试验速览

暂无简介。

•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

•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
•1.1Hemodialysis, AKI, CKI or any clinical evidence (e.g., high serum BUN level) that may need protein restriction
•2.2Disease that may associated with muscle atrophy or weakness (Duchenne muscular atrophy, ALS, etc.)
•3.3Systemic malignant tumor (brain, lung, gastric, colon, liver, breast and etc.)
•4.4Liver cirrhosis – Child’s class C liver disease
•5.5Hematologic disease ?acute myeloid leukemia, acute lymphocytic leukemia or other disease-causing thrombocytopenia (< 50 000 x10³/uL) or coagulopathy (> 2 INR)?.
•6.6Post-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

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