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NCT03944330 Clinical Trial

A Study on Nutrition Support Therapy of Patients With Liver Failure

Nutrition Clinical Trial

Official title:
A Clinic Trail on Nutrition Support Therapy of Patients With Liver Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03944330
Other study ID # Nstlf
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 10, 2019
Est. completion date June 1, 2022

Study information
Verified date May 2019
Source Tongji Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date June 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• standard hospital diet
patients were provided standard hospital diet that provided 25-30 kcal/kg/day

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Tongji Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality at 30 day The percentage of death of liver failure patients at 4 weeks 4 weeks
Secondary liver transplant-free survival survival rate on 4 weeks and 3 month 3month
Secondary Laboratory variables on serum biochemistry markers Laboratory variables on serum lever of glutamic-pyruvic transaminase/glutamic oxalacetic transaminase/total bilirubin/ cholinesterase will be combined to report liver function 3month
Secondary Laboratory variables on fasting blood sugar Laboratory variables on serum lever of fasting blood sugar 3month
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