Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk

Study Overview
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Brief Summary
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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
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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).

Official Title
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Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk: a Randomized Controlled Trail

Conditions
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Malnutrition, Hepatitis B,Chronic, Acute-On-Chronic Liver Failure, Nutrition Support

Intervention / Treatment
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* Dietary Supplement: Individual nutritional support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trail Group<br>30 patients will receive dietary counseling and individual nutrition support treatment based on Oral nutrition supplements and supplemented by parenteral nutrition. | Dietary Supplement: Individual nutritional support<br>* Nutritional products and route（oral, parenteral）is possible to reach goals<br>|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplant free survival at 30 days |  | 30 days | 
| Transplant free survival at 90 days |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| L3-SMI as a marker of muscle mass | Third lumbar skeletal muscle index(L3-SMI) by CT scan | 30 days, 90days | 
| Grip as markers of muscle strength | Grip | 30 days, 90days | 
| Short Physical Performance Battery (SPPB) as markers of physical performance | The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. | 30 days, 90 days | 
| Improvement in quality of life | Improvement in quality of life measured with the EuroQol Group 5-Dimension Self-Report Questionnaire on admission and during follow up measured by patient interview | 30 days, 90days | 
| length of hospital stay | days in the hospital within index hospitalisation and within the 90 days of follow up measured by patient interview and medical chart review | days in the hospital within index hospitalisation and within the 30 days of follow up measured by patient interview and medical chart review | 
| Energy intake | Protein-calorie intake as assessed by serial 24-hour dietary recall | 10 days | 
| hepatic adverse outcomes | hepatic encephalopathy，esophageal variceal hemorrhage，etc | 10days,30 days, 90 days | 
| Combined safety endpoints in regard to side effects from nutritional therapy | Number of participants with side effects from nutritional support including (a) adverse gastrointestinal effects (diarrhea, nausea, vomiting, abdominal pain, abdominal distention) assessed by patient interview (yes/no) b) Complications due to center catheter for parenteral nutrition assessed by medical chart review (c) Refeeding syndrome assessed by chart review (d) Acute pancreatitis defined as 2 out of 3 criteria: abdominal pain, 3-fold increase in lipase or amylase, characteristic imaging findings assessed by chart review (e) Liver or gall bladder dysfunction assessed by chart review (f) Hyperglycemia (defined as glucose levels persistent levels >10mmol/l in patients without diabetes or well controlled diabetes) assessed by medical chart review | measured at day 10 and 30 |