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

Not Applicable

Recruiting

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0009672
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 230

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified