Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk: a Randomized Controlled Trail
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Transplant free survival at 90 days
Study Overview
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), tailored nutritional therapy to reach nutritional targets based on individualized nutritional counseling is a effective strategy to prevent mortality, morbidity and functional decline.
Sixty patients with HBV related ACLF will be enrolled in this study. The participants are divided into trial Patients in the trail group will receive individualized nutritional therapy to reach nutritional targets (caloric, protein, others) based on a predefined nutritional strategy.In control patients, according to patients' appetite, standard hospital nutrition will be served. Nutritional therapy may be started in control patients, if any sort of swallowing disorders develops or if patients need to be prepared for operation. All patients will be re-assessed daily during the hospital stay for nutritional intake and nutritional therapy may be escalated within first 3days ( oral supplements, parenteral nutrition) if targets are not met (at least 75% of targets).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Trail Group
30 patients will receive dietary counseling and individual nutrition support treatment based on Oral nutrition supplements and supplemented by parenteral nutrition.
Intervention: Individual nutritional support (Dietary Supplement)
Control Group
30 patients will receive standard care food provided by the hospital kitchen according to their ability and desire, standard care food provided by the hospital kitchen.
Outcomes
Primary Outcomes
Transplant free survival at 90 days
Time Frame: 90 days
Transplant free survival at 30 days
Time Frame: 30 days
Secondary Outcomes
- Improvement in quality of life(30 days, 90days)
- hepatic adverse outcomes(10days,30 days, 90 days)
- length of hospital stay(days in the hospital within index hospitalisation and within the 30 days of follow up measured by patient interview and medical chart review)
- Short Physical Performance Battery (SPPB) as markers of physical performance(30 days, 90 days)
- L3-SMI as a marker of muscle mass(30 days, 90days)
- Grip as markers of muscle strength(30 days, 90days)
- Energy intake(10 days)
- Combined safety endpoints in regard to side effects from nutritional therapy(measured at day 10 and 30)
Investigators
Liang Peng
Professor
Third Affiliated Hospital, Sun Yat-Sen University