Hospital General de Mexico
Mexico City, 06720, Mexico
NCT Number: NCT03923933
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Mexico City, 06720, Mexico
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Chlorthalidone
Bumetanide
Time frame: Change from Basal to day 28
Measured by bioelectrical impedance analysis, compared to the initial measurement
Time frame: Change from Basal to day 28
decrease in blood pressure compared wit baseline measure (mmhg)
Time frame: Change from Basal to day 28
Increase in the fractional excretion of sodium compared with the baseline measure
Time frame: Change from Basal to day 28
Decrease in extracellular water measured by bioelectrical impedance analysis
Time frame: Change from Basal to day 28
Decrease in extracellular water / total body water ratio measured by bioelectrical impedance analysis
Time frame: Change from Basal to day 28
Time frame: Change from Basal to day 28
Hospital General de México Dr. Eduardo Liceaga
Other Gov
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