Clinical trial NCT06128421: Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk
Official title: Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk: a Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malnutrition
Hepatitis B,Chronic
Acute-On-Chronic Liver Failure
Nutrition Support
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. Age from 20 to 60 years old;
2. Clinical diagnosis of chronic hepatitis b virus infection(positive hepatitis b surface antigen or positive hepatitis b virus DNA \>0.5 year
3. serum total bilirubin level ≥12 mg/dl
4. prothrombin time international ratio ≥1.5
5. NRS≥ 3points
6. COSSH-ACLF IIs \<8.4 points

Exclusion Criteria:

1. Other active liver disease;
2. Hepatocellular carcinoma or other malignancy, HIV, Chronic kidney disease(CKD), diabetes, thyroid disease, cardiopulmonary disease, neuromuscular diseases, serious psychiatric disease;
3. Acute cholecystitis, acute pancreatitis, biliary obstruction, short bowel syndrome, intestinal obstruction, inflammatory bowel disease;
4. Severe complications or other organ failure including sever infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal failure(AGI III-IV);
5. Pregnancy, BMI\<18.5 or BMI ≥28，organ transplantation, bed-ridden;
6. Unable to ingest oral nutrition, contraindication against parenteral nutrition
7. Admitted with enteral or parenteral nutrition in the last week
8. expected hospital length of stay\<3 days，.expected residence in Guangdong Province length of live\< 90 days

Primary outcomes:
measure: Transplant free survival at 30 days
timeFrame: 30 days
measure: Transplant free survival at 90 days
timeFrame: 90 days
Secondary outcomes:
measure: L3-SMI as a marker of muscle mass
timeFrame: 30 days, 90days
measure: Grip as markers of muscle strength
timeFrame: 30 days, 90days
measure: Short Physical Performance Battery (SPPB) as markers of physical performance
timeFrame: 30 days, 90 days
measure: Improvement in quality of life
timeFrame: 30 days, 90days
measure: length of hospital stay
timeFrame: days in the hospital within index hospitalisation and within the 30 days of follow up measured by patient interview and medical chart review
measure: Energy intake
timeFrame: 10 days
measure: hepatic adverse outcomes
timeFrame: 10days,30 days, 90 days
measure: Combined safety endpoints in regard to side effects from nutritional therapy
timeFrame: measured at day 10 and 30
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: