Status:
RECRUITING
Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Malnutrition
Hepatitis B,Chronic
Eligibility:
All Genders
20-60 years
Phase:
NA
Brief Summary
This study aims to investigate the safety and efficacy of individual nutrition support for treating hepatitis b virus(HBV) related acute-on-chronic liver failure patients at nutrition risk
Detailed Description
The aims of the randomized-controlled trial are to test the hypothesis that in medical inpatients with HBV related ACLF at risk for undernutrition defined by the nutritional risk score (NRS 2002), tai...
Eligibility Criteria
Inclusion
- Age from 20 to 60 years old;
- Clinical diagnosis of chronic hepatitis b virus infection(positive hepatitis b surface antigen or positive hepatitis b virus DNA \>0.5 year
- serum total bilirubin level ≥12 mg/dl
- prothrombin time international ratio ≥1.5
- NRS≥ 3points
- COSSH-ACLF IIs \<8.4 points
Exclusion
- Other active liver disease;
- Hepatocellular carcinoma or other malignancy, HIV, Chronic kidney disease(CKD), diabetes, thyroid disease, cardiopulmonary disease, neuromuscular diseases, serious psychiatric disease;
- Acute cholecystitis, acute pancreatitis, biliary obstruction, short bowel syndrome, intestinal obstruction, inflammatory bowel disease;
- Severe complications or other organ failure including sever infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal failure(AGI III-IV);
- Pregnancy, BMI\<18.5 or BMI ≥28，organ transplantation, bed-ridden;
- Unable to ingest oral nutrition, contraindication against parenteral nutrition
- Admitted with enteral or parenteral nutrition in the last week
- expected hospital length of stay\<3 days，.expected residence in Guangdong Province length of live\< 90 days
Key Trial Info
Start Date :
November 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06128421
Start Date
November 23 2023
End Date
October 31 2024
Last Update
January 25 2024
Active Locations (1)
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1
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630