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

NCT ID: NCT01977430

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-03-31

Brief Summary

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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:

* 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.

Detailed Description

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Conditions

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Chronic Kidney Insufficiency Hemodialysis Treatment Diuresis Preserved

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Hydrochlorothiazide and furosemide

Intervention Type 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

Control Arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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Maria Isabel Bolós Contador

Medica Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mabel - Bolos-Contador, MD

Role: PRINCIPAL_INVESTIGATOR

Corporacion Parc Tauli

Locations

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Corporació Sanitària Parc Taulí

Sabadell, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Mabel - Bolos-Contador, MD

Role: CONTACT

[email protected]
0034 937231010 ext. 25010

Facility Contacts

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Mabel - Bolos-Contador, MD

Role: primary

[email protected]
0034937231010 ext. 25010

Other Identifiers

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CSPT2013/058

Identifier Type: OTHER

Identifier Source: secondary_id

NEF-DIU-2013-CSPT

Identifier Type: -

Identifier Source: org_study_id