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

November 4, 2020 updated by: Fabio Solis-Jimenez, Hospital General de México Dr. Eduardo Liceaga

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 06720
        • Hospital General de Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
This group will receive 3 milligrams of bumetanide per day for a week plus placebo (starch) that will simulate the chlorthalidone dose of the treatment group. In case the dose is well tolerated, the dose of bumetanide will be increased to 4 milligrams per day.
Drug: Bumetanide
Bumetanide
Experimental: Treatment grup
This group will receive 3 milligrams of bumetanide plus 50 milligrams of chlorthalidone per day, for a week. If the dose is well tolerated, it will be increased to 4 milligrams of bumetanide and 100 milligrams of chlorthalidone per day.
Drug: Bumetanide
Bumetanide
Drug: Chlorthalidone
Chlorthalidone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total Body Water
Time Frame: Change from Basal to day 28
Measured by bioelectrical impedance analysis, compared to the initial measurement
Change from Basal to day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean Arterial Pressure
Time Frame: Change from Basal to day 28
decrease in blood pressure compared wit baseline measure (mmhg)
Change from Basal to day 28
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
Change from Basal to day 28
Change in Extracellular Water
Time Frame: Change from Basal to day 28
Decrease in extracellular water measured by bioelectrical impedance analysis
Change from Basal to day 28
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
Change from Basal to day 28
Change in Systolic Blood Pressure
Time Frame: Change from Basal to day 28
Change from Basal to day 28
Change in Diastolic Blood Pressure
Time Frame: Change from Basal to day 28
Change from Basal to day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General de México Dr. Eduardo Liceaga

Investigators

  • Principal Investigator: Fabio Solis-Jimenez, M.D., Hospital General de México Dr. Eduardo Liceaga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2019

Primary Completion (Actual)

October 28, 2019

Study Completion (Actual)

October 28, 2019

Study Registration Dates

First Submitted

April 18, 2019

First Submitted That Met QC Criteria

April 22, 2019

First Posted (Actual)

April 23, 2019

Study Record Updates

Last Update Posted (Actual)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DI/19/105-B/03/018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Insufficiency, Chronic

Clinical Trials on Bumetanide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe