Clinical Trial to Compare Effectiveness of Diuretics in Hemodialysis Patients With Residual Renal Function

Chronic Kidney Insufficiency Clinical Trial

— RRF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01977430
• Other study ID #: NEF-DIU-2013-CSPT
• Secondary ID: CSPT2013/058
• Status: Recruiting
• Phase: Phase 4
• First received: October 24, 2013
• Last updated: November 30, 2014
• Start date: November 2013
• Est. completion date: March 2015

Study information

• Verified date: March 2014
• Source: Corporacion Parc Tauli
• Contact: Mabel - Bolos-Contador, MD
• Phone: 0034 937231010
• Email: mabeline17[@]hotmail.com
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Insufficiency
• Diuresis Preserved
• Hemodialysis Treatment
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Hydrochlorothiazide and furosemide
This clinical trial is cross-over study. The diuretic arm's patients will receive combined diuretic treatment for 1 month: 20 mg of furosemide three times daily and 50 mg of hydrochlorothiazide twice daily

Locations

Country	Name	City	State
Spain	Corporació Sanitària Parc Taulí	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To asses the effect of combined hydrochlorothiazide-furosemide therapy on weight gain between haemodialysis sessions in patients with RRF	Gain weight	14 weeks	No
Secondary	To asses the effect of combined hydrochlorothiazide-furosemide therapy on dialytic, clinical and analytical variables and use of the antihypertensive treatment	Variations of the next parameters in the different periods(15 days, 1, 2 and 3 months) of the clinical trial: urine volume, reduction of ultrafiltration in interdialysis sessions and long interdialytic interval, dry weight, blood pressure intradialysis,plasma potassium, plasma bicarbonate, plasma uric acid, urinary sodium, urinary chloro and urinary potassium in interdialytic sessions . Use of the antihypertensive treatment. To Appear complications for example: hypotensions, cramps and symptomatic hyperuricemia. Creatinine clearance and urea clearance. Use of potassium treatment intradialysis.	14 weeks	Yes