Chang Gung Memorial Hospital, Chiayi Branch
Chiayi City, 613, Taiwan
NCT Number: NCT04295044
Our prior studies demonstrated that dehydration was a predictor for poor outcome in stroke and Blood urea nitrogen/Cr ratio-based saline hydration therapy in patients with acute ischemic stroke may increase the rate of favorable clinical outcome with functional independence at 3 months after stroke. However, dehydration is likely to be only a part of representation in poor nutrition status and physical fragility for a stroke patient.
Our prior study found that acute stroke patients admitted to neurological intensive care unit with low urinary creatinine excretion rate (CER), a marker of muscle mass, was associated with poor outcome at 6 months after stroke. An animal study suggested inadequate food and water intake determine mortality following stroke in mice and nutritional support reduced the 14-day mortality rate from 59% to 15%. A study also showed that high protein intake was associated with a better outcome in previous cardiovascular events.
We will calculate CER based on published equation. Based on our prior study, acute stroke patients with their CER<1500 mg/day will be enrolled. A randomized controlled trial will be conducted and patients will be randomly assigned to high protein diet or normal protein diet for at least 2 weeks. We plan to enroll 300 patients, with 150 patients in ach group, during 3-year study period. We will consult dietitians for arrangement of their diet. We assume that patients receiving high protein diet will have higher opportunity to walk independently (modified Rankin Scale 0-1) at 3 month after stroke.
Looking for future studies?
Notify Me20 year–99 year
All sexes
Interventional
Phase 2
Chiayi City, 613, Taiwan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
receive 1.8g protein/kg
receive 1g protein/kg
Time frame: 3 months
No significant disability
Time frame: 3 months
Slight disability
Chang Gung Memorial Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05416853
Arterial Occlusive Diseases, Brain Diseases
Hefei, Anhui, China
View Trial DetailsNCT07709806
Brain Diseases, Cardiovascular Diseases
Siping, Jilin, China
View Trial DetailsNCT07654582
Brain Diseases, Cardiovascular Diseases
Cairo, Egypt
View Trial DetailsNCT06049498
Brain Diseases, Cardiovascular Diseases
Beijing, China
View Trial Details