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Trial record 93 of 242 for:    furosemide

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
Sponsor:
Information provided by (Responsible Party):
Maria Isabel Bolós Contador, Corporacion Parc Tauli

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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Insufficiency Hemodialysis Treatment Diuresis Preserved Drug: Hydrochlorothiazide and furosemide Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Mabel - Bolos-Contador, MD 0034 937231010 ext 25010 mabeline17@hotmail.com

Locations
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Spain
Corporació Sanitària Parc Taulí Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Mabel - Bolos-Contador, MD    0034937231010 ext 25010    mabeline17@hotmail.com   
Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
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Principal Investigator: Mabel - Bolos-Contador, MD Corporacion Parc Tauli

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Responsible Party: Maria Isabel Bolós Contador, Medica Doctor, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT01977430     History of Changes
Other Study ID Numbers: NEF-DIU-2013-CSPT
CSPT2013/058 ( Other Identifier: Ethics Committee Corporació Sanitària Parc Taulí )
First Posted: November 6, 2013    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: March 2014
Keywords provided by Maria Isabel Bolós Contador, Corporacion Parc Tauli:
Residual renal function
Combined thiazide-furosemide therapy
Haemodialysis
Additional relevant MeSH terms:
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Furosemide
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Hydrochlorothiazide
Diuretics
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Potassium Chloride Symporter Inhibitors