Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128421
• Other study ID #: PL17
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: January 2024
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Li Zhipeng
• Phone: +8613725480127
• Email: lzp1219[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis B,Chronic
• Liver Failure
• Malnutrition
• Nutrition Support

Intervention

Dietary Supplement:
• Individual nutritional support
Nutritional products and route(oral, parenteral)is possible to reach goals

Locations

Country	Name	City	State
China	Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transplant free survival at 30 days		30 days
Primary	Transplant free survival at 90 days		90 days
Secondary	L3-SMI as a marker of muscle mass	Third lumbar skeletal muscle index(L3-SMI) by CT scan	30 days, 90days
Secondary	Grip as markers of muscle strength	Grip	30 days, 90days
Secondary	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
Secondary	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
Secondary	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
Secondary	Energy intake	Protein-calorie intake as assessed by serial 24-hour dietary recall	10 days
Secondary	hepatic adverse outcomes	hepatic encephalopathy,esophageal variceal hemorrhage,etc	10days,30 days, 90 days
Secondary	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