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Completed

NCT Number: NCT03923933

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

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorthalidone

Drug

Chlorthalidone

Bumetanide

Drug

Bumetanide

Primary outcomes

  1. Change in Total Body Water

    Time frame: Change from Basal to day 28

    Measured by bioelectrical impedance analysis, compared to the initial measurement

Secondary outcomes

  1. Change in Mean Arterial Pressure

    Time frame: Change from Basal to day 28

    decrease in blood pressure compared wit baseline measure (mmhg)

  2. Change in the Fractional Excretion of Sodium

    Time frame: Change from Basal to day 28

    Increase in the fractional excretion of sodium compared with the baseline measure

  3. Change in Extracellular Water

    Time frame: Change from Basal to day 28

    Decrease in extracellular water measured by bioelectrical impedance analysis

  4. Change in Extracellular Water / Total Body Water Ratio

    Time frame: Change from Basal to day 28

    Decrease in extracellular water / total body water ratio measured by bioelectrical impedance analysis

  5. Change in Systolic Blood Pressure

    Time frame: Change from Basal to day 28

  6. Change in Diastolic Blood Pressure

    Time frame: Change from Basal to day 28

Sponsors and collaborators

Lead sponsor

Hospital General de México Dr. Eduardo Liceaga

Other Gov

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 23, 2019
Registry last updated
Nov 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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