NCT00741663

Brief Summary

The question whether the sequential diuretic therapy, that means using an antialdosteronic drug at first and adding a loop diuretic in nonresponders, is better than the combination of the two diuretics from the beginning (combined diuretic therapy) in the treatment of ascites in patients with cirrhosis is still open. Therefore, the aim of the study is to compare sequential versus combined diuretic therapy in these patients. One hundred patients will be randomized into two groups. Group A will receive potassium canrenoate at the initial dose of 200 mg/day, then increased up to 400 mg/day. Non responders will be treated with 400 mg/day of potassium canrenoate and furosemide at an initial dose of 50 mg/day, then increased up to 150 mg/day. Group B will receive at first 200 mg/day of potassium canrenoate and 50 mg/day of furosemide, then increased up to 400 mg/day and 150 mg/day, respectively. The percentage of responders to dthe diuretic treatment, the time to get the resolution of ascites and the rate of adverse effects will be compared between the two Groups of Patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

April 1, 2005

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2008

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

September 25, 2008

Status Verified

September 1, 2008

Enrollment Period

3.4 years

First QC Date

August 22, 2008

Last Update Submit

September 24, 2008

Conditions

CirrhosisAscites

Keywords

cirrhosisascitesdiuretic therapypotassium canrenoatefurosemidehyperkalemiaplasma renin activitynitric oxideserum sodium concentrationrefractory ascitesNonazotemic patients with cirrhosis and moderate ascites

Outcome Measures

Primary Outcomes (2)

  • the percentage of responders to the diuretic treatment; the percentage of patients who develop adverse effects to diuretics

    within three weeks

  • the percentage of patients who will respond to the diuretic treatment, the percentage of patients who will develop adverse effects to diuretics

    within three weeks

Secondary Outcomes (1)

  • time to get the response to diuretics

    within three weeks

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: Spironolactone and furosemide

B

EXPERIMENTAL
Drug: Spironolactone and furosemide

Interventions

Spironolactone and furosemideDRUG

Patients in arm A will receive potassium canrenoate at the initial dose of 200 mg/day, then increased up to 400 mg/day. Non responders will be treated with 400 mg/day of potassium canrenoate and furosemide at an initial dose of 50 mg/day, then increased up to 150 mg/day.

A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Grade 2 ascites
  • Serum creatinine less than 1.2 mtg/dl
  • Serum sodium \> 130 mmol/l
  • Serum potassium within 3.5 and 4.5 mmol/l
  • At least five days after the withdrawal of diuretics
  • A 90 mmol/day Na diet.

You may not qualify if:

  • Cardiac or respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Padova, Dept. of Clinical and Experimental Medicine

Padua, 35100, Italy

Location

Related Publications (2)

  • Santos J, Planas R, Pardo A, Durandez R, Cabre E, Morillas RM, Granada ML, Jimenez JA, Quintero E, Gassull MA. Spironolactone alone or in combination with furosemide in the treatment of moderate ascites in nonazotemic cirrhosis. A randomized comparative study of efficacy and safety. J Hepatol. 2003 Aug;39(2):187-92. doi: 10.1016/s0168-8278(03)00188-0.

    PMID: 12873814RESULT

  • Angeli P, Fasolato S, Mazza E, Okolicsanyi L, Maresio G, Velo E, Galioto A, Salinas F, D'Aquino M, Sticca A, Gatta A. Combined versus sequential diuretic treatment of ascites in non-azotaemic patients with cirrhosis: results of an open randomised clinical trial. Gut. 2010 Jan;59(1):98-104. doi: 10.1136/gut.2008.176495.

    PMID: 19570764DERIVED

MeSH Terms

Conditions

FibrosisAscitesHyperkalemia

Interventions

SpironolactoneFurosemide

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSulfanilamidesSulfonamidesAmidesAniline CompoundsAminesSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2008

First Posted

August 26, 2008

Study Start

April 1, 2005

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

September 25, 2008

Record last verified: 2008-09

Locations

IT(1)