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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Nutritional products and route（oral, parenteral）is possible to reach goals
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGTransplant free survival at 30 days
Time frame: 30 days
Transplant free survival at 90 days
Time frame: 90 days
L3-SMI as a marker of muscle mass
Third lumbar skeletal muscle index(L3-SMI) by CT scan
Time frame: 30 days, 90days
Grip as markers of muscle strength
Grip
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 10 days
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hepatic adverse outcomes
hepatic encephalopathy，esophageal variceal hemorrhage，etc
Time frame: 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
Time frame: measured at day 10 and 30