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

• Status: Completed
• Trial end date: 2019-10-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital General de México Dr. Eduardo Liceaga
• Treatments: Bumetanide; Chlorthalidone

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