Cirrhosis Registry of Hospitalized Patients (RH7)

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

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

Study Overview

• Status: Recruiting
• Conditions: Frailty; Ascites; Infection; Cirrhosis, Liver; Encephalopathy

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Janka Vnencakova, PhD; Phone Number: +421902160743; Email: janka.vnencakova1@gmail.com

Study Locations

• Slovakia
  • Banska Bystrica, Slovakia, 97401
    • Recruiting
    • F.D.Roosevelt Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Included are patients with liver cirrhosis and indication for hospital admission who are or are not candidates for liver transplant and have or do not have liver cancer

Description

Inclusion Criteria:

• liver cirrhosis (primarily on clinical grounds)
• decompensating event leading to hospital admission
• informed consent

Exclusion Criteria:

• declined consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Adults with liver cirrhosis admitted to hospital liver unit; Consenting adults admitted with liver cirrhosis; recorded/uploaded are demographic, clinical, laboratory and imaging data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and type of decompensation of liver cirrhosis	Registrations reflect cirrhosis prevalence; decompensation are acute, chronic, or acute-on-chronic	"1 year"
Mortality	Record mortality in registered cirrhotics	"1 year"

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Record mortality in registered cirrhotics	90-day
Mortality	Record mortality in registered cirrhotics	1 year
Frailty	Measurement of the liver frailty index	On admission

Collaborators and Investigators

• Sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
• Investigators: Principal Investigator: Lubomir Skladany, MD PhD, F.D.Roosevelt Teaching Hospital, Banska Bystrica, Slovakia

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2014
• Primary Completion (ACTUAL): February 2, 2021
• Study Completion (ANTICIPATED): December 31, 2029

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: February 21, 2021
• First Posted (ACTUAL): February 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: frailty; Cirrhosis; decompensation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Fibrosis; Liver Cirrhosis; Frailty; Brain Diseases; Ascites
• Other Study ID Numbers: HEGITO2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing by request primarily by investigators from other centres, editors of medical journals, authors of meta analyses, etc
• IPD Sharing Time Frame: On request, immediately, open ended
• IPD Sharing Access Criteria: GDPR compliance Medical Journal Editorial office approved person Auditing authority Approved scientist
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

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