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

NCT01977430 | Unknown Phase 4 DMC

• 2 other identifiers: NEF-DIU-2013-CSPTCSPT2013/058
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Insufficiency; Hemodialysis Treatment; Diuresis Preserved

Keywords

Residual renal function; Combined thiazide-furosemide therapy; Haemodialysis

Outcome Measures

Primary Outcomes (1)

• To asses the effect of combined hydrochlorothiazide-furosemide therapy on weight gain between haemodialysis sessions in patients with RRF

  Gain weight

  14 weeks

Secondary Outcomes (1)

• To asses the effect of combined hydrochlorothiazide-furosemide therapy on dialytic, clinical and analytical variables and use of the antihypertensive treatment

  14 weeks

Study Arms (2)

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

Drug: Hydrochlorothiazide and furosemide

Control Arm

NO INTERVENTION

Interventions

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

Diuretics arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Hydrochlorothiazide; Furosemide

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfanilamides; Amides; Aniline Compounds; Amines

Study Officials

• Mabel - Bolos-Contador, MD

  Corporacion Parc Tauli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mabel - Bolos-Contador, MD

CONTACT

0034 937231010; mabeline17@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medica Doctor

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 6, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 2, 2014

Record last verified: 2014-03

Locations

ES (1)