Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2023
CompletedFirst Posted
Study publicly available on registry
November 13, 2023
CompletedStudy Start
First participant enrolled
November 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedJanuary 25, 2024
January 1, 2024
5 months
November 6, 2023
January 24, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Transplant free survival at 30 days
30 days
Transplant free survival at 90 days
90 days
Secondary Outcomes (8)
L3-SMI as a marker of muscle mass
30 days, 90days
Grip as markers of muscle strength
30 days, 90days
Short Physical Performance Battery (SPPB) as markers of physical performance
30 days, 90 days
Improvement in quality of life
30 days, 90days
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
- +3 more secondary outcomes
Study Arms (2)
Trail Group
EXPERIMENTAL30 patients will receive dietary counseling and individual nutrition support treatment based on Oral nutrition supplements and supplemented by parenteral nutrition.
Control Group
NO INTERVENTION30 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.
Interventions
Nutritional products and route（oral, parenteral）is possible to reach goals
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Related Publications (1)
Li Z, Luo Q, Wang P, Wang L, Zheng X, Zhang Y, Xu W, Peng L. Efficacy and safety of individual nutrition support in patients with hepatitis B virus-related acute-on-chronic liver failure at nutrition risk: a study protocol for a randomised controlled clinical trial. BMJ Open. 2024 Dec 9;14(12):e088832. doi: 10.1136/bmjopen-2024-088832.
PMID: 39653573DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 6, 2023
First Posted
November 13, 2023
Study Start
November 23, 2023
Primary Completion
April 30, 2024
Study Completion
October 31, 2024
Last Updated
January 25, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share