Clinical Trial to Compare Effectiveness of Diuretics in Hemodialysis Patients With Residual Renal Function (RRF)
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|ClinicalTrials.gov Identifier: NCT01977430|
Recruitment Status : Unknown
Verified March 2014 by Maria Isabel Bolós Contador, Corporacion Parc Tauli.
Recruitment status was: Recruiting
First Posted : November 6, 2013
Last Update Posted : December 2, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Insufficiency Hemodialysis Treatment Diuresis Preserved||Drug: Hydrochlorothiazide and furosemide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||November 2013|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||March 2015|
Experimental: Diuretics arm
The diuretic arm's patients will receive combined thiazide-furosemide therapy for 1 month: 20 mg of furosemide three times daily and 50 mg of hydrochlorothiazide twice daily
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
|No Intervention: Control Arm|
- To asses the effect of combined hydrochlorothiazide-furosemide therapy on weight gain between haemodialysis sessions in patients with RRF [ Time Frame: 14 weeks ]Gain weight
- To asses the effect of combined hydrochlorothiazide-furosemide therapy on dialytic, clinical and analytical variables and use of the antihypertensive treatment [ Time Frame: 14 weeks ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977430
|Contact: Mabel - Bolos-Contador, MD||0034 937231010 ext email@example.com|
|Corporació Sanitària Parc Taulí||Recruiting|
|Sabadell, Barcelona, Spain, 08208|
|Contact: Mabel - Bolos-Contador, MD 0034937231010 ext 25010 firstname.lastname@example.org|
|Principal Investigator:||Mabel - Bolos-Contador, MD||Corporacion Parc Tauli|