Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk

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

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

Study Overview

• Status: Recruiting
• Conditions: Acute-On-Chronic Liver Failure; Malnutrition; Nutrition Support; Hepatitis B,Chronic
• Intervention / Treatment: Dietary supplement: Individual nutritional support

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li Zhipeng; Phone Number: +8613725480127; Email: lzp1219@126.com
• Study Contact Backup: Name: Peng Liang; Phone Number: +8613533978874; Email: pzp33@hotmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Recruiting
      • Third Affiliated Hospital of Sun Yat-sen University
      • Contact: Liang Peng, Doctor; Phone Number: +8613533978874; Email: pzp33@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trail Group; 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; Nutritional products and route（oral, parenteral）is possible to reach goals
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Hepatic Insufficiency; Pathologic Processes; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Liver Failure, Acute; Nutrition Disorders; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Chronic; Hepatitis; Chronic Disease; End Stage Liver Disease; Liver Failure; Acute-On-Chronic Liver Failure; Hepatitis B; Hepatitis B, Chronic; Malnutrition
• Other Study ID Numbers: PL17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No