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

Hospital General de México Dr. Eduardo Liceaga

Status and phase: Completed; Phase 2

Conditions: Renal Insufficiency, Chronic

Treatments: Drug: Bumetanide; Drug: Chlorthalidone

Study type: Interventional

Funder types: Other

Identifiers

NCT03923933

DI/19/105-B/03/018

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Bumetanide

Treatment grup

Experimental group

Description:

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.

Treatment:

Drug: Chlorthalidone

Drug: Bumetanide