A Study on Nutrition Support Therapy of Patients With Liver Failure

Not Applicable

• Conditions: Nutrition
• Interventions: Dietary Supplement: standard hospital diet

• Registration Number: NCT03944330
• Lead Sponsor: Tongji Hospital

Brief Summary

This study is a Clinical trial to assess the efficacy of nutrition support therapy of patients with liver failure. Patients were randomized to one of 2 groups to receive different nutrition and energy support treatment.

Detailed Description

Patients with liver failure (defined by APASL) induced by any precipitating factors were randomized to two groups; a treatment group and a control group. Participants in treatment group were provided with a standard hospital diet that provided 25-30 kcal/kg/day . Patients in control group receive diet guide

Study Timeline

• Study First Submitted: 2019-03-14
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-08
• Last Update Submitted: 2019-05-08
• Study First Posted: 2019-05-09
• Last Update Posted: 2019-05-09
• Study Start: 2019-05-10
• Primary Completion: 2022-04-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male and female patients from 18 to 65 years of age;
2. Patient inclusion criteria: jaundice (serum total bilirubin ≥5 mg/dl) and coagulopathy (INR ≥ 1.5 or prothrombin activity ≥ 40 %), accompanied by ascites and/or encephalopathy within 4 weeks.

Exclusion Criteria

1. Surgery with in 4 weeks
2. three degree hepatoencephalopathy
3. malignant tumors
4. cardiac failure or respiratory failure
5. liver transplantation within observing period -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
a treatment group	standard hospital diet	All study participants were provided with a standard hospital diet that provided B25-30 kcal/kg/day

Primary Outcome Measures

Name	Time	Method
Mortality at 30 day	4 weeks	The percentage of death of liver failure patients at 4 weeks

Secondary Outcome Measures

Name	Time	Method
Laboratory variables on serum biochemistry markers	3month	Laboratory variables on serum lever of glutamic-pyruvic transaminase/glutamic oxalacetic transaminase/total bilirubin/ cholinesterase will be combined to report liver function
Laboratory variables on fasting blood sugar	3month	Laboratory variables on serum lever of fasting blood sugar
liver transplant-free survival	3month	survival rate on 4 weeks and 3 month