Study to compare the efficacy of diuretics in patients in hemodialysis with residual diuresis

• Conditions: Chronic renal disease stage V in hemodialysis; MedDRA version: 16.0Level: LLTClassification code 10051051Term: Renal diseaseSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2013-003214-41-ES
• Lead Sponsor: Fundació Parc Taulí

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-16
• Last Update Posted: 2 December 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients older than 18 years of age.
Patients with chronic renal disease in stage V in Hemodialysis.
Patients that keep a residual renal function (diuresis equal or greater than 200 ml per day.
Patients who have been in hemodialysis for at least 3 months at the time of inclusion in the study.
Patients giving informed consent to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Patients in hemodialysis with plasma K concentrations lower than 4 mEq/L during the inter HD period in short days.
Patients in HD requiring K suplements in the dialysis.
Patients with inter HD weight gain in long days lower than 1 kg.
Patients with history of adverse events or hypersensibility to the study treatments.
Patients not giving informed consent to participate in the study.
Pregnant women or nursing mothers.
Patients with contraindications to the administration of any of the study diuretics or to the concomitant administraion of both drugs, according to the SPCs.
Patients that the investigator in charge of the medical care considers the participation in the study would be detrimental.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of combined use of furosemide and hydrochlorothiazide on interdialysis weight gain in patients in HD with residual renal function;Secondary Objective: To assess the effects of combined use of furosemide and hydrochlorothiazide on the following parameters:<br>Diuresis<br>REduccion of ultrafiltrate in short and long days inter HD<br>Dry weight<br>Blood pressure in short and long and long days inter HD<br>Plasma K concentration in short inter HD days<br>Na, K and Cl in urine in short inter HD days<br>Hipotension, cramps and gout episodes<br>Use of hipotensive drugs<br>HCO3 and uric acid plasma concentration in short HD days<br>Creatinine and urine clearance<br>Use of K supplements in HD<br><br>To assess the safety of the administraion of furosemide and hydroclorotiazide in this patient population;Primary end point(s): Inter HD weight gain in long days at the end of each period;Timepoint(s) of evaluation of this end point: 4 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Difference between diuresis at baseline and at the end of each study treatment;Timepoint(s) of evaluation of this end point: 4 weeks