Clinical trial NCT03923933: Chlortalidone and Bumetanide in Advanced Chronic Kidney Disease: HEBE-CKD Trial
Official title: Chlortalidone and Bumetanide in Advanced Chronic Kidney Disease: HEBE-CKD Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Insufficiency, Chronic
Keywords: Diuretics
Bumetanide
Chlorthalidone
Chronic Kidney Disease
Volume Overload
Lead sponsor: Hospital General de México Dr. Eduardo Liceaga
Sponsor class: OTHER_GOV
First posted: 2019-04-23
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Total Body Water
timeFrame: Change from Basal to day 28
Secondary outcomes:
measure: Change in Mean Arterial Pressure
timeFrame: Change from Basal to day 28
measure: Change in the Fractional Excretion of Sodium
timeFrame: Change from Basal to day 28
measure: Change in Extracellular Water
timeFrame: Change from Basal to day 28
measure: Change in Extracellular Water / Total Body Water Ratio
timeFrame: Change from Basal to day 28
measure: Change in Systolic Blood Pressure
timeFrame: Change from Basal to day 28
measure: Change in Diastolic Blood Pressure
timeFrame: Change from Basal to day 28
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital General de Mexico
Study officials:
affiliation: Hospital General de México Dr. Eduardo Liceaga
name: Fabio Solis-Jimenez, M.D.
role: PRINCIPAL_INVESTIGATOR
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