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

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05167305
• Other study ID #: ILBS-COVID-07
• Status: Completed
• Start date: December 22, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2021
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1316
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Other:
• This is an observational study
This is an observational study

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of 30 days readmission rate of patients of liver disease.		Day 30
Secondary	Comparison of 31 to 90 days readmission rate of patients of liver disease.		Day 31-90
Secondary	Comparison of liver transplantation rates in the two time periods i.e., April-May 2021 and April-May 2019.		3 months