Chlortalidone and Bumetanide in Advanced Chronic Kidney Disease: HEBE-CKD Trial

NCT ID: NCT03923933

Last Updated: 2020-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-18
• Study Completion Date: 2019-10-28

Brief Summary

This study aims to demonstrate the possible benefit of a treatment based on double diuretic in patients with chronic kidney disease and severely impaired glomerular filtration rate. This is based on previous observations where the investigators found that volume overload is a frequent condition within this population and is strongly linked to an increase in morbidity and mortality. The investigators consider that this therapy could be beneficial given that most of these patients are treated with loop diuretics, however, with the passage of time, adaptive changes in the distal nephron occur that promote a decrease in the treatment effect. In this sense, thiazide diuretics at appropriate doses could 'break' the resistance, since their mechanism of action antagonizes the resistance mechanism. Unfortunately, to this day, this treatment has not been fully evaluated. Particularly in this type of population.

The investigators developed a study proposed as a double blind randomized clinical trial, where the population will be divided into two groups. A group will be given the standard treatment based on loop diuretic (bumetanide), while the other group will receive the intervention (bumetanide plus chlorthalidone). After a 30-day follow-up period, the results will be measured.

With respect to the effectiveness of the treatment, the decrease in volume overload by bioimpedance will be measured. While the occurrence of adverse effects during the same monitoring period will be observed.

Conditions

Renal Insufficiency, Chronic

Keywords

Diuretics; Bumetanide; Chlorthalidone; Chronic Kidney Disease; Volume Overload

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

This group will receive 3 milligrams of bumetanide per day for a week plus placebo (starch) that will simulate the chlorthalidone dose of the treatment group. In case the dose is well tolerated, the dose of bumetanide will be increased to 4 milligrams per day.

Group Type: PLACEBO_COMPARATOR

Bumetanide

Intervention Type: DRUG

Bumetanide

Treatment grup

This group will receive 3 milligrams of bumetanide plus 50 milligrams of chlorthalidone per day, for a week. If the dose is well tolerated, it will be increased to 4 milligrams of bumetanide and 100 milligrams of chlorthalidone per day.

Group Type: EXPERIMENTAL

Chlorthalidone

Intervention Type: DRUG

Chlorthalidone

Bumetanide

Intervention Type: DRUG

Bumetanide

Interventions

Chlorthalidone

Chlorthalidone

Intervention Type: DRUG

Bumetanide

Bumetanide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• glomerular filtration rate less than 30 ml / min / 1.73m
• Without replacement therapy (dialysis or hemodialysis)
• Volume overload
• At least 100 ml per day of residual diuresis
• Use of a loop diuretic for at least one month

Exclusion Criteria

• Allergies known to diuretics
• Patients with severe infections
• Patients with hemodynamic instability
• Amputees
• Patients with cognitive impairment
• Patients with acute renal failure
• Patients with graft loss

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital General de México Dr. Eduardo Liceaga

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fabio Solis-Jimenez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabio Solis-Jimenez, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital General de México Dr. Eduardo Liceaga

Locations

Hospital General de Mexico

Mexico City, , Mexico

Countries

Mexico

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

DI/19/105-B/03/018

Identifier Type: -

Identifier Source: org_study_id