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NCT04767945 Clinical Trial

Cirrhosis Registry of Hospitalized Patients

Infection Clinical Trial

— RH7  

Official title:
Registry of Adult Consenting Patients Admitted to the Liver Unit With Liver Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04767945
Other study ID # HEGITO2014
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2014
Est. completion date December 31, 2029

Study information
Verified date August 2022
Source F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Contact Lubomir Skladany, MD, PhD
Phone +421905482997
Email lubomir.skladany@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Cirrhosis registry of consecutive adult consenting patients hospitalized with liver cirrhosis in the tertiary liver unit

Description:

On admission to F.D.Roosevelt Teaching Hospital / HEGITO Liver Unit (Div Hepatology, Gastroenterology and Liver Transplant), all the adult patients with liver cirrhosis are offered to participate. After providing informed consent, their demographic, clinical and laboratory / imaging data are uploaded by dedicated study person After discharge from the hospital, follow-up is recommended and uploaded to RH7 (if the follow-up visits take place at this institution [FDR]) Mortality data are uploaded from the national registry of dead on regular basis

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date December 31, 2029
Est. primary completion date February 2, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - liver cirrhosis (primarily on clinical grounds) - decompensating event leading to hospital admission - informed consent Exclusion Criteria: - declined consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Slovakia F.D.Roosevelt Teaching Hospital Banska Bystrica

Sponsors (1)
Lead Sponsor Collaborator
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Country where clinical trial is conducted

Slovakia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency and type of decompensation of liver cirrhosis Registrations reflect cirrhosis prevalence; decompensation are acute, chronic, or acute-on-chronic "1 year"
Primary Mortality Record mortality in registered cirrhotics "1 year"
Secondary Mortality Record mortality in registered cirrhotics 90-day
Secondary Mortality Record mortality in registered cirrhotics 1 year
Secondary Frailty Measurement of the liver frailty index On admission
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