IMPACT OF OUTPATIENT INTENSIVE NUTRITION THERAPY ON SURVIVAL AND FRAILTY IN PATIENTS WITH ACUTE-ON-CHRONIC LIVER FAILURE: AN OPEN LABEL RANDOMISED TRIA

Post Graduate Institute of Medical Education and Research PGIMER0 个研究点目标入组 70 人开始时间: 待定最近更新: 2023年2月6日

试验速览

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•A. Age more than 18 years and less than 75 years
•B. Patients with a confirmed diagnosis of Acute-on-chronic liver failure by APASL criteria
•APASL ACLF defined by serum bilirubin more than and equal to 5 mg/dl & coagulopathy (INR more than equal to 1.5 or PT less than 40%), complicated within 4 weeks by ascites and/or encephalopathy in a patient with chronic liver disease
•C. Presence of frailty

•1. Patients with AARC score more than 10
•2. Patients with MELD score more than 30
•3. Obese patient (BMI more than 25kg/m2)
•4. Patients with active malignancy, hepatocellular carcinoma and, the end-stage renal disease.
•5. Active alcohol abuse at the time of enrollment
•6. Patients having prior study enrollment or enrollment in another conflicting study
•7. Patients, who are not willing to participate in the study, will be excluded.
•8. Patients who are participating in other clinical trials within past 3 months
•9. Patients who has an active evidence of infection
•10. Patients who had acute organic brain disease in the past 6 months
•11. Patients who have severe hemodynamic instability, serious heart disease, severe bradycardia, or tachycardia at rest
•12. Patients having renal failure (creatinine clearance rate less than and equal to 60 mL/min/1.73 m2)
•13. Patients who are not able to perform the strength exercise; severe cognitive impairment (Mini-Mental State Examination less than and equal to 17), overt hepatic encephalopathy, or patients who had physical disability)

发起方

Post Graduate Institute of Medical Education and Research PGIMER