Clinical Trial to Compare Effectiveness of Diuretics in Hemodialysis Patients With Residual Renal Function (RRF)
Primary Purpose
Chronic Kidney Insufficiency, Hemodialysis Treatment, Diuresis Preserved
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Hydrochlorothiazide and furosemide
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Insufficiency focused on measuring Residual renal function, Combined thiazide-furosemide therapy, Haemodialysis
Eligibility 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.
Sites / Locations
- Corporació Sanitària Parc TaulíRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Diuretics arm
Control Arm
Arm Description
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
Outcomes
Primary Outcome Measures
To asses the effect of combined hydrochlorothiazide-furosemide therapy on weight gain between haemodialysis sessions in patients with RRF
Gain weight
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01977430
First Posted
October 24, 2013
Last Updated
November 30, 2014
Sponsor
Corporacion Parc Tauli
1. Study Identification
Unique Protocol Identification Number
NCT01977430
Brief Title
Clinical Trial to Compare Effectiveness of Diuretics in Hemodialysis Patients With Residual Renal Function
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
March 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Insufficiency, Hemodialysis Treatment, Diuresis Preserved
Keywords
Residual renal function, Combined thiazide-furosemide therapy, Haemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diuretics arm
Arm Type
Experimental
Arm Description
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
Arm Title
Control Arm
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Hydrochlorothiazide and furosemide
Intervention Description
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
Primary Outcome Measure Information:
Title
To asses the effect of combined hydrochlorothiazide-furosemide therapy on weight gain between haemodialysis sessions in patients with RRF
Description
Gain weight
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
To asses the effect of combined hydrochlorothiazide-furosemide therapy on dialytic, clinical and analytical variables and use of the antihypertensive treatment
Description
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.
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mabel - Bolos-Contador, MD
Phone
0034 937231010
Ext
25010
Email
mabeline17@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mabel - Bolos-Contador, MD
Organizational Affiliation
Corporacion Parc Tauli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corporació Sanitària Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mabel - Bolos-Contador, MD
Phone
0034937231010
Ext
25010
Email
mabeline17@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Compare Effectiveness of Diuretics in Hemodialysis Patients With Residual Renal Function
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