NCT02163512

Brief Summary

Multicentric, observational and prospective study with two groups of treatment: Refractory ascites and non-refractory ascites. All patients should be prescribed beta-adrenergic blockers as primary or secondary profilaxis for variceal bleeding.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

February 11, 2019

Status Verified

June 1, 2016

Enrollment Period

4.1 years

First QC Date

June 10, 2014

Last Update Submit

February 8, 2019

Conditions

Hepatic Cirrhosis

Keywords

Hepatic cirrhosisAscitesBeta blockers treatment

Outcome Measures

Primary Outcomes (2)

  • Cardiac function

    * Echocardiography: changes in left ventricular ejection fraction, cardiac output, * Electrocardiography: changes in Qt interval

    Baseline and after 4 weeks

  • Kidney function

    * Echocardiography: Renal vascular Doppler ultrasonographic parameters (resistive index of kidney arteries) * Blood test: serum creatinine, estimated glomerular filtration rate (eGFR) calculated by the Modification of Diet in Renal Disease formula, IL18, KIM1, NGAL

    Baseline and after 4 weeks

Secondary Outcomes (1)

  • Inflammatory markers and vasoactive endogenous system

    Baseline and after 4 weeks

Study Arms (2)

Non-refractory ascites

Refractory ascites

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with hepatic cirrhoris and refractory or non-refractory ascites. These patients are going to be treated with beta blockers as primary or secondary prophylaxis of variceal bleeding

You may qualify if:

  • Patients aged 18-80
  • Patients previously prescribed with beta-blockers
  • Any type of hepatic cirrosis that has been diagnosed by clinical, analytic and image criteria
  • Mild to serious ascites. Classification on refractory or non-refractory ascites depends on the patient´s response to diuretic treatment. Refractory ascites is defined by the Ascites´Board International Criteria as the lack of response, ascites recurrency or complications occurrence by diuretic drugs uptake
  • Esophageal varicose vein in which beta blockers treatment is indicated as primary or secondary prophylaxis. Primary prophylaxis is indicated for big esophageal varicose veins, small varicose veins with red signs or varicose veins in patients with B-C Child-Pugh stage. Secondary prophylaxis is indicated for all those patients that have previously presented varicose bleeding.
  • Patients giving a written consent to participate in the study after having received enough information about the design, objectives and risks.

You may not qualify if:

  • Hepatocellular carcinoma \>5 cm
  • Total portal vein thrombosis or Cavernous transformation of the portal vein
  • Insuficiencia renal (creatinina sérica \>3 mg/dl).
  • Kidney insufficiency (seric creatinine \>3 mg/dl)
  • Contraindications to beta-blockers: Cardiac or breathing insufficiency, auricular-ventricular blocking grade \>1.
  • Anticoagulant treatment
  • Patients with a intrahepatic portosystemic shunt
  • Beta-blockers Hypersensitivity
  • Pregnancy and breastfeeding
  • Women of childbearing age must commit to undergo an effective contraception during the treatment and at least one month after finishing it.
  • Patients with severe controlled or not controlled psychiatric condition
  • Patients´ lack of commitment to follow all visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Related Publications (1)

  • Tellez L, Ibanez-Samaniego L, Perez Del Villar C, Yotti R, Martinez J, Carrion L, Rodriguez de Santiago E, Rivera M, Gonzalez-Mansilla A, Pastor O, Bermejo J, Banares R, Albillos A. Non-selective beta-blockers impair global circulatory homeostasis and renal function in cirrhotic patients with refractory ascites. J Hepatol. 2020 Dec;73(6):1404-1414. doi: 10.1016/j.jhep.2020.05.011. Epub 2020 May 21.

    PMID: 32446716DERIVED

MeSH Terms

Conditions

Liver CirrhosisAscites

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 13, 2014

Study Start

March 12, 2014

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

February 11, 2019

Record last verified: 2016-06

Locations

ES(2)