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

Renal Insufficiency, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03923933
• Other study ID #: DI/19/105-B/03/018
• Status: Completed
• Phase: Phase 2
• Start date: June 18, 2019
• Est. completion date: October 28, 2019

Study information

• Verified date: November 2020
• Source: Hospital General de México Dr. Eduardo Liceaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 28, 2019
• Est. primary completion date: October 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Chlorthalidone
Chlorthalidone
• Bumetanide
Bumetanide

Locations

Country	Name	City	State
Mexico	Hospital General de Mexico	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de México Dr. Eduardo Liceaga

Country where clinical trial is conducted

Mexico, 

References & Publications (49)

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* Note: There are 49 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Body Water	Measured by bioelectrical impedance analysis, compared to the initial measurement	Change from Basal to day 28
Secondary	Change in Mean Arterial Pressure	decrease in blood pressure compared wit baseline measure (mmhg)	Change from Basal to day 28
Secondary	Change in the Fractional Excretion of Sodium	Increase in the fractional excretion of sodium compared with the baseline measure	Change from Basal to day 28
Secondary	Change in Extracellular Water	Decrease in extracellular water measured by bioelectrical impedance analysis	Change from Basal to day 28
Secondary	Change in Extracellular Water / Total Body Water Ratio	Decrease in extracellular water / total body water ratio measured by bioelectrical impedance analysis	Change from Basal to day 28
Secondary	Change in Systolic Blood Pressure		Change from Basal to day 28
Secondary	Change in Diastolic Blood Pressure		Change from Basal to day 28