NCT05167305

Brief Summary

Hospital record of the patients of liver disease admitted from April-May 2021 and April-May 2019 will be reviewed. Patients will be analyzed and compared for the demographic characteristics, severity of liver disease at time of admission and outcome in form of survival or mortality, liver transplantation rates in the two time periods and the subsequent 30 d and 90 day readmission rate. Monitoring and assessment: Hospital records of all patients of liver disease needing admission during the April-May 2019 and 2021, but without active COVID-19 infection, will be reviewed. Patients will be analyzed and compared for the demographic characteristics, severity of liver disease at time of admission and outcome in form of survival or mortality, liver transplantation rates in the two time periods and 30 d and 90 d readmission rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,316

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

December 22, 2021

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

9 days

First QC Date

December 17, 2021

Last Update Submit

December 31, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison of in-hospital mortality rate of patients of liver disease admitted in April-May 2021 and April-May 2019.

    Until discharge or death

Secondary Outcomes (3)

  • Comparison of 30 days readmission rate of patients of liver disease.

    Day 30

  • Comparison of 31 to 90 days readmission rate of patients of liver disease.

    Day 31-90

  • Comparison of liver transplantation rates in the two time periods i.e., April-May 2021 and April-May 2019.

    3 months

Study Arms (2)

liver disease without COVID-19 infection-April-May 2019

Other: This is an observational study

liver disease without COVID-19 infection -April- May 2021

Other: This is an observational study

Interventions

This is an observational study

liver disease without COVID-19 infection -April- May 2021liver disease without COVID-19 infection-April-May 2019

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of liver disease without COVID-19 infection admitted in the time period April- May 2021 and April-May 2019.

You may qualify if:

  • Patients of liver disease requiring hospital admission

You may not qualify if:

  • Active COVID-19 infection at time of admission or acquiring during hospital stay.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2021

First Posted

December 22, 2021

Study Start

December 22, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 4, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations