The Second COVID-19 Wave: Collateral Impact on Patients of Liver Disease

The Second COVID-19 Wave: Collateral Impact on Patients of Liver Disease-A Record Based Cross-Sectional Study.

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.

Study Overview

• Status: Completed
• Conditions: Liver Diseases
• Intervention / Treatment: Other: This is an observational study

• Study Type: Observational
• Enrollment (Actual): 1316

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Patients of liver disease requiring hospital admission

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
liver disease without COVID-19 infection-April-May 2019	Other: This is an observational study; This is an observational study
liver disease without COVID-19 infection -April- May 2021	Other: This is an observational study; This is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 31, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: ILBS-COVID-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No