CClinicalTrials.gg
RecruitingNCT04767945RH7Updated Aug 3, 2022

Cirrhosis Registry of Hospitalized Patients

An observational study in Cirrhosis, Liver, Frailty and Ascites, sponsored by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica. Recruiting at 1 site in Slovakia. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-08-03.

Sponsored by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Cirrhosis, Liver
  • Frailty
  • Ascites
  • Encephalopathy
  • Infection

Keywords

  • Cirrhosis
  • decompensation
  • frailty
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • declined consent
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Target follow-up
15 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Adults with liver cirrhosis admitted to hospital liver unit

    Consenting adults admitted with liver cirrhosis; recorded/uploaded are demographic, clinical, laboratory and imaging data

05

What researchers measure

Primary outcomes

  1. Frequency and type of decompensation of liver cirrhosis

    Registrations reflect cirrhosis prevalence; decompensation are acute, chronic, or acute-on-chronic

    Time frame: "1 year"

  2. Mortality

    Record mortality in registered cirrhotics

    Time frame: "1 year"

Secondary outcomes

  1. Mortality

    Record mortality in registered cirrhotics

    Time frame: 90-day

  2. Mortality

    Record mortality in registered cirrhotics

    Time frame: 1 year

  3. Frailty

    Measurement of the liver frailty index

    Time frame: On admission

06

Study locations

1 of 1 sites recruiting
  • F.D.Roosevelt Teaching Hospital
    Banska Bystrica, 97401, Slovakia
    • Lubomir Skladany, MD, PhD · Contact · lubomir.skladany@gmail.com · +421905482997
    • Natalia Bystrianska, MD · Contact · naty2121@centrum.sk · +421917944393
    • Daniela Jancekova, MD · Sub investigator
    • Janka Vnencakova, MD · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — Sharing by request primarily by investigators from other centres, editors of medical journals, authors of meta analyses, etc

Supporting information: Study protocol, Icf, Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04767945
Lead sponsor
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
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) — Principal investigator
First posted
Feb 23, 2021
Start date
Jul 1, 2014
Primary completion
Feb 2, 2021
Completion
Dec 31, 2029 (estimated)
Last update
Aug 3, 2022

Study contacts

Lubomir Skladany, MD, PhD
Contact
lubomir.skladany@gmail.com
+421905482997
Janka Vnencakova, PhD
Contact
janka.vnencakova1@gmail.com
+421902160743
Lubomir Skladany, MD PhD
principal investigator · F.D.Roosevelt Teaching Hospital, Banska Bystrica, Slovakia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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