NCT03944330

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

May 10, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

2.9 years

First QC Date

March 14, 2019

Last Update Submit

May 8, 2019

Conditions

Nutrition

Outcome Measures

Primary Outcomes (1)

  • Mortality at 30 day

    The percentage of death of liver failure patients at 4 weeks

    4 weeks

Secondary Outcomes (3)

  • liver transplant-free survival

    3month

  • Laboratory variables on serum biochemistry markers

    3month

  • Laboratory variables on fasting blood sugar

    3month

Study Arms (2)

a treatment group

ACTIVE COMPARATOR

All study participants were provided with a standard hospital diet that provided B25-30 kcal/kg/day

Dietary Supplement: standard hospital diet

control group

NO INTERVENTION

All study participants were not intervened with diet

Interventions

standard hospital dietDIETARY_SUPPLEMENT

patients were provided standard hospital diet that provided 25-30 kcal/kg/day

a treatment group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients from 18 to 65 years of age;

You may not qualify if:

  • Surgery with in 4 weeks
  • three degree hepatoencephalopathy
  • malignant tumors
  • cardiac failure or respiratory failure
  • liver transplantation within observing period -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director and Chair of Department of Infectious Diseases

Study Record Dates

First Submitted

March 14, 2019

First Posted

May 9, 2019

Study Start

May 10, 2019

Primary Completion

April 1, 2022

Study Completion

June 1, 2022

Last Updated

May 9, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share