Phase 2
N=34
Chlortalidone and Bumetanide in Advanced Chronic Kidney Disease: HEBE-CKD Trial
Renal Insufficiency, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT03923933 ↗Enrolled (actual)
34
Serious AEs
3.1%
Results posted
Mar 2020
Primary outcome: Primary: Change in Total Body Water — -0.075; -4.36 litres — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Chlorthalidone (Drug); Bumetanide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital General de México Dr. Eduardo Liceaga
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Body Water |
-0.075; -4.36 | <0.001 sig |
| SECONDARY Change in Mean Arterial Pressure |
-5.4; -18.1 | 0.006 sig |
| SECONDARY Change in the Fractional Excretion of Sodium |
-0.348; 0.598 | 0.371 |
| SECONDARY Change in Extracellular Water |
-0.15; 2.55 | <0.001 sig |
| SECONDARY Change in Extracellular Water / Total Body Water Ratio |
-0.24; -2.92 | — |
| SECONDARY Change in Systolic Blood Pressure |
-10; -26.1 | 0.028 sig |
| SECONDARY Change in Diastolic Blood Pressure |
-3.4; -13.5 | 0.018 sig |
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
Data sourced from ClinicalTrials.gov (NCT03923933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.