Back to resultsA Study on Nutrition Support Therapy of Patients With Liver Failure
Primary Purpose
Nutrition
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
standard hospital diet
Sponsored by
About this trial
This is an interventional supportive care trial for Nutrition
Eligibility Criteria
Inclusion Criteria:
- Male and female patients from 18 to 65 years of age;
- 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:
- Surgery with in 4 weeks
- three degree hepatoencephalopathy
- malignant tumors
- cardiac failure or respiratory failure
- liver transplantation within observing period -
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
a treatment group
control group
Arm Description
All study participants were provided with a standard hospital diet that provided B25-30 kcal/kg/day
All study participants were not intervened with diet
Outcomes
Primary Outcome Measures
Mortality at 30 day
The percentage of death of liver failure patients at 4 weeks
Secondary Outcome Measures
liver transplant-free survival
survival rate on 4 weeks and 3 month
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
Laboratory variables on fasting blood sugar
Laboratory variables on serum lever of fasting blood sugar
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03944330
Brief Title
A Study on Nutrition Support Therapy of Patients With Liver Failure
Official Title
A Clinic Trail on Nutrition Support Therapy of Patients With Liver Failure
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2019 (Anticipated)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
a treatment group
Arm Type
Active Comparator
Arm Description
All study participants were provided with a standard hospital diet that provided B25-30 kcal/kg/day
Arm Title
control group
Arm Type
No Intervention
Arm Description
All study participants were not intervened with diet
Intervention Type
Dietary Supplement
Intervention Name(s)
standard hospital diet
Intervention Description
patients were provided standard hospital diet that provided 25-30 kcal/kg/day
Primary Outcome Measure Information:
Title
Mortality at 30 day
Description
The percentage of death of liver failure patients at 4 weeks
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
liver transplant-free survival
Description
survival rate on 4 weeks and 3 month
Time Frame
3month
Title
Laboratory variables on serum biochemistry markers
Description
Laboratory variables on serum lever of glutamic-pyruvic transaminase/glutamic oxalacetic transaminase/total bilirubin/ cholinesterase will be combined to report liver function
Time Frame
3month
Title
Laboratory variables on fasting blood sugar
Description
Laboratory variables on serum lever of fasting blood sugar
Time Frame
3month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients from 18 to 65 years of age;
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:
Surgery with in 4 weeks
three degree hepatoencephalopathy
malignant tumors
cardiac failure or respiratory failure
liver transplantation within observing period -
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study on Nutrition Support Therapy of Patients With Liver Failure
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