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| ID | Type | Description | Link |
|---|---|---|---|
| CSPT2013/058 | Other Identifier | Ethics Committee Corporació Sanità ria Parc Taulà |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diuretics arm | Experimental | 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 |
|
| Control Arm | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrochlorothiazide and furosemide | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To asses the effect of combined hydrochlorothiazide-furosemide therapy on weight gain between haemodialysis sessions in patients with RRF | Gain weight | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mabel - Bolos-Contador, MD | Contact | 0034 937231010 | 25010 | mabeline17@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mabel - Bolos-Contador, MD | Corporacion Parc Tauli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporació Sanità ria Parc Taulà | Recruiting | Sabadell | Barcelona | 08208 | Spain |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D006852 | Hydrochlorothiazide |
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
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| 14 weeks |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013457 |
| Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013424 | Sulfanilamides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |