Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trail Group | Experimental | 30 patients will receive dietary counseling and individual nutrition support treatment based on Oral nutrition supplements and supplemented by parenteral nutrition. |
|
| Control Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual nutritional support | Dietary Supplement | Nutritional products and route(oral, parenteral)is possible to reach goals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transplant free survival at 30 days | 30 days | |
| Transplant free survival at 90 days | 90 days |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zhipeng | Contact | +8613725480127 | lzp1219@126.com | |
| Peng Liang | Contact | +8613533978874 | pzp33@hotmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510630 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39653573 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D019694 | Hepatitis B, Chronic |
| D065290 | Acute-On-Chronic Liver Failure |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017114 | Liver Failure, Acute |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |