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出境医 / 临床实验 / A Study on Nutrition Support Therapy of Patients With Liver Failure

A Study on Nutrition Support Therapy of Patients With Liver Failure

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 Intervention/treatment Phase
Nutrition Dietary Supplement: standard hospital diet Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 10, 2019
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : June 1, 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
No Intervention: control group
All study participants were not intervened with diet
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
Layout table for eligibility information
Ages Eligible for Study:   18 Years 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

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE March 14, 2019
First Posted Date  ICMJE May 9, 2019
Last Update Posted Date May 9, 2019
Estimated Study Start Date  ICMJE May 10, 2019
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019) 		Mortality at 30 day [ Time Frame: 4 weeks ]
The percentage of death of liver failure patients at 4 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • liver transplant-free survival [ Time Frame: 3month ]
    survival rate on 4 weeks and 3 month
  • 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
  • Laboratory variables on fasting blood sugar [ Time Frame: 3month ]
    Laboratory variables on serum lever of fasting blood sugar
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study on Nutrition Support Therapy of Patients With Liver Failure
Official Title  ICMJE A Clinic Trail on Nutrition Support Therapy of Patients With Liver Failure
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Nutrition
Intervention  ICMJE Dietary Supplement: standard hospital diet
patients were provided standard hospital diet that provided 25-30 kcal/kg/day
Study Arms  ICMJE
  • Active Comparator: a treatment group
    All study participants were provided with a standard hospital diet that provided B25-30 kcal/kg/day
    Intervention: Dietary Supplement: standard hospital diet
  • No Intervention: control group
    All study participants were not intervened with diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 8, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2022
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03944330
Other Study ID Numbers  ICMJE Nstlf
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Qin Ning, Tongji Hospital
Study Sponsor  ICMJE Tongji Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tongji Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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