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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

A Study on Nutrition Support Therapy of Patients With Liver Failure

Clinicaltrials.gov identifier NCT03944330

Recruitment Status Not yet recruiting

First Posted May 9, 2019

Last update posted May 9, 2019

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.

  • Condition or Disease:Nutrition
  • Intervention/Treatment: Dietary Supplement: standard hospital diet
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Supportive Care
  • Official Title: A Clinic Trail on Nutrition Support Therapy of Patients With Liver Failure
  • Estimated Study Start Date: May 2019
  • Estimated Primary Completion Date: April 2022
  • Estimated Study Completion Date: June 2022
Arms and interventions
Arm Intervention/treatment
Active Comparator: a treatment group
All study participants were provided with a standard hospital diet that provided B25-30 kcal/kg/day
Dietary Supplement: standard hospital diet
patients were provided standard hospital diet that provided 25-30 kcal/kg/day
Outcome Measures
  • Primary Outcome Measures: 1. Mortality at 30 day [ Time Frame: 4 weeks ]
    The percentage of death of liver failure patients at 4 weeks
  • Secondary Outcome Measures: 1. liver transplant-free survival [ Time Frame: 3month ]
    survival rate on 4 weeks and 3 month
  • 2. Laboratory variables on serum biochemistry markers [ Time Frame: 3month ]
    Laboratory variables on serum lever of glutamic-pyruvic transaminase/glutamic oxalacetic transaminase/total bilirubin/ cholinesterase will be combined to report liver function
  • 3. Laboratory variables on fasting blood sugar [ Time Frame: 3month ]
    Laboratory variables on serum lever of fasting blood sugar
Eligibility Criteria
  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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 -

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Tongji Hospital

More Information
  • Responsible Party: Tongji Hospital
  • ClinicalTrials.gov Identifier: NCT03944330 History of Changes
  • Other Study ID Numbers: Nstlf
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: May 9, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Liver Failure