Clinical trial NCT01977430: Clinical Trial to Compare Effectiveness of Diuretics in Hemodialysis Patients With Residual Renal Function
Official title: Randomized Open Clinical Trial to Compare the Effectiveness of the Administration of Diuretics in Hemodialysis Patients With Residual Renal Function in Single Centre
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Kidney Insufficiency
Hemodialysis Treatment
Diuresis Preserved
Keywords: Residual renal function
Combined thiazide-furosemide therapy
Haemodialysis
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Introduction: Chronic kidney disease is characterized by a progressive deterioration of renal function. At the end of the progression, when complications occur (overhydration, electrolyte imbalances or retention of uremic toxins), a percentage of patients requiring renal replacement therapy (haemodialysis). When starting the haemodialysis, the patient holds the residual renal function (RRF) which is lost over time. To preserve the RRF, the patient is treated with diuretics loops and / or thiazide diuretics. The effect of this treatment is lost when renal function worsens. In this context, there are few studies that explore the use and effectiveness of diuretics in patients on haemodialysis 2. Objectives and Hypothesis:

Hypothesis: The treatment with furosemide and hydrochlorothiazide in haemodialysis patients with RRF could:

* To decrease in weight gain between haemodialysis sessions.
* To increase urine volume.
* To decrease the ultrafiltration in haemodialysis sessions ( the long interdialytic interval)

Main Objective:To asses the effect of combined hydrochlorothiazide-furosemide therapy on gain weight between haemodialysis sessions in patients with RRF

Secondary Objective: To asses the effect of combined hydrochlorothiazide-furosemide therapy on dialytic, clinical and analytical variables and use of the antihypertensive treatment

3. Methodology: Randomized open clinical trial to compare the effectiveness of the administration of diuretics in haemodialysis patients with residual renal function in single centre.

The population of study are patients with chronic renal disease in haemodialysis therapy that they preserve residual renal function ( more 200ml daily of urine). It will be a simple randomization, to asses the effect of combined hydrochlorothiazide-furosemide therapy

After a of 15 days washout without diuretic treatment, patients will be randomized to receive or not receive combined diuretic treatment for 1 month. After a 1 month washout , the patients will be receive or not the treatment according to cross over trial.


Eligibility criteria: Inclusion Criteria:

* Over 18 years
* Chronic kidney disease, stage 5 Chronic Kidney Disease, in haemodialysis
* Renal residual function preserved(more or equal 200 ml daily of urine)
* Minimum 3 months on haemodialysis and wish to participate in this study

Exclusion criteria:

* Less 4 millequivalent of potassium plasma in interdialytic sessions or to require potassium intradialytic treatment.
* Less 1 Kg of gain weight in the long interdialytic interval.
* Adverse effects with treatment in the past.
* To refusal to participate in the study.
* Pregnancy or lactation period.
* Contraindication the use of diuretic therapy, according to pharmacological profile.

Primary outcomes:
measure: To asses the effect of combined hydrochlorothiazide-furosemide therapy on weight gain between haemodialysis sessions in patients with RRF
timeFrame: 14 weeks
Secondary outcomes:
measure: To asses the effect of combined hydrochlorothiazide-furosemide therapy on dialytic, clinical and analytical variables and use of the antihypertensive treatment
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
Study officials:
affiliation: Corporacion Parc Tauli
name: Mabel - Bolos-Contador, MD
role: PRINCIPAL_INVESTIGATOR
References: