RH7: Cirrhosis Registry of Hospitalized Patients

Sponsor

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica (Other)

Overall Status

Recruiting

CT.gov ID

NCT04767945

Collaborator

(none)

2,000

Enrollment

Location

186

Anticipated Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis, Liver Frailty Ascites Encephalopathy Infection

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Feb 2, 2021

Anticipated Study Completion Date :

Dec 31, 2029

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Frequency and type of decompensation of liver cirrhosis ["1 year"]
Registrations reflect cirrhosis prevalence; decompensation are acute, chronic, or acute-on-chronic
Mortality ["1 year"]
Record mortality in registered cirrhotics

Secondary Outcome Measures

Mortality [90-day]
Record mortality in registered cirrhotics
Mortality [1 year]
Record mortality in registered cirrhotics
Frailty [On admission]
Measurement of the liver frailty index

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

declined consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	F.D.Roosevelt Teaching Hospital	Banska Bystrica		Slovakia	97401

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ľubomír Skladaný MD, PhD, Head, Department of Internal Medicine and HEGITO Liver Unit, Principal Investigator, F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

ClinicalTrials.gov Identifier:

NCT04767945

Other Study ID Numbers:

HEGITO2014

First Posted:

Feb 23, 2021

Last Update Posted:

Aug 3, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ľubomír Skladaný MD, PhD, Head, Department of Internal Medicine and HEGITO Liver Unit, Principal Investigator, F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Cirrhosis

decompensation

frailty

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022