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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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. |
|
| Treatment grup | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorthalidone | Drug | Chlorthalidone |
| |
| Bumetanide |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Body Water | Measured by bioelectrical impedance analysis, compared to the initial measurement | Change from Basal to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Arterial Pressure | decrease in blood pressure compared wit baseline measure (mmhg) | Change from Basal to day 28 |
| Change in the Fractional Excretion of Sodium | Increase in the fractional excretion of sodium compared with the baseline measure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabio Solis-Jimenez, M.D. | Hospital General de México Dr. Eduardo Liceaga | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Mexico | Mexico City | 06720 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28430830 | Background | Bello AK, Levin A, Tonelli M, Okpechi IG, Feehally J, Harris D, Jindal K, Salako BL, Rateb A, Osman MA, Qarni B, Saad S, Lunney M, Wiebe N, Ye F, Johnson DW. Assessment of Global Kidney Health Care Status. JAMA. 2017 May 9;317(18):1864-1881. doi: 10.1001/jama.2017.4046. | |
| 29225940 | Background | Neuen BL, Chadban SJ, Demaio AR, Johnson DW, Perkovic V. Chronic kidney disease and the global NCDs agenda. BMJ Glob Health. 2017 Jul 6;2(2):e000380. doi: 10.1136/bmjgh-2017-000380. eCollection 2017. No abstract available. |
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Patients were recruited from the nephrology clinic in the Hospital General de México, between May and August 2019. All those with stage 4-5 chronic kidney disease, who had chronic use of loop diuretics and hypertension, were invited to perform an impedance measurement. Those with volume overload were invited to participate in the protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Bumetanide: Bumetanide |
| FG001 | 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. Chlorthalidone: Chlorthalidone Bumetanide: Bumetanide |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Bumetanide: Bumetanide |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Total Body Water | Measured by bioelectrical impedance analysis, compared to the initial measurement | Posted | Mean | Standard Deviation | litres | Change from Basal to day 28 |
|
28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Bumetanide: Bumetanide |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major adverse cardiovascular events | Cardiac disorders | Systematic Assessment | Nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Creatinine Increase | Renal and urinary disorders | Systematic Assessment | increase in serum creatinine levels greater than 0.3 mg / dl compared to baseline |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rafael Vadez-Ortiz M.D. PhD | Head of Nephrology Hospital General de México | +52 2789-2000 | 1253 | rafavaldez@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2019 | Feb 19, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D004487 | Edema |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002752 | Chlorthalidone |
| D002034 | Bumetanide |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
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| Drug |
Bumetanide |
|
| Change from Basal to day 28 |
| Change in Extracellular Water | Decrease in extracellular water measured by bioelectrical impedance analysis | Change from Basal to day 28 |
| 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 |
| Change in Systolic Blood Pressure | Change from Basal to day 28 |
| Change in Diastolic Blood Pressure | Change from Basal to day 28 |
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| 15292685 | Background | Chang ST, Chen CL, Chen CC, Lin FC, Wu D. Enhancement of quality of life with adjustment of dry weight by echocardiographic measurement of inferior vena cava diameter in patients undergoing chronic hemodialysis. Nephron Clin Pract. 2004;97(3):c90-7. doi: 10.1159/000078636. |
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| 11856788 | Background | Wilcox CS. New insights into diuretic use in patients with chronic renal disease. J Am Soc Nephrol. 2002 Mar;13(3):798-805. doi: 10.1681/ASN.V133798. |
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| 36127661 | Derived | Solis-Jimenez F, Perez-Navarro LM, Cabrera-Barron R, Chida-Romero JA, Martin-Alemany G, Dehesa-Lopez E, Madero M, Valdez-Ortiz R. Effect of the combination of bumetanide plus chlorthalidone on hypertension and volume overload in patients with chronic kidney disease stage 4-5 KDIGO without renal replacement therapy: a double-blind randomized HEBE-CKD trial. BMC Nephrol. 2022 Sep 20;23(1):316. doi: 10.1186/s12882-022-02930-4. |
| 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. Chlorthalidone: Chlorthalidone Bumetanide: Bumetanide |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Total body water | Median | Full Range | liters |
|
| Extracellular water | Median | Full Range | liters |
|
| Extracellular water/Total Body Water | Mean | Standard Deviation | percentage |
|
| systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Mean arterial pressure | Mean | Standard Deviation | mmHg |
|
| serum creatinine | Median | Full Range | mg/dL |
|
| serum urea | Median | Full Range | mg/dL |
|
| glomerular filtration rate | Mean | Standard Deviation | ml/min/1.73m2 |
|
| Cause of chronic kidney disease | Count of Participants | Participants |
|
| Seric sodium | Mean | Standard Deviation | meq/l |
|
| serum potassium | Mean | Standard Deviation | meq/l |
|
| Urinary sodium | Mean | Standard Deviation | meq/l |
|
| Urinary chlorine | Mean | Standard Deviation | meq/l |
|
|
|
|
| Secondary | Change in Mean Arterial Pressure | decrease in blood pressure compared wit baseline measure (mmhg) | Posted | Mean | Standard Deviation | 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 | Posted | Mean | Standard Deviation | percentage of sodium excreted | Change from Basal to day 28 |
|
|
|
|
| Secondary | Change in Extracellular Water | Decrease in extracellular water measured by bioelectrical impedance analysis | Posted | Mean | Standard Deviation | litres | 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 | Posted | Mean | Standard Deviation | percentage of ECW/TBW | Change from Basal to day 28 |
|
|
|
| Secondary | Change in Systolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | Change from Basal to day 28 |
|
|
|
|
| Secondary | Change in Diastolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | Change from Basal to day 28 |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 4 |
| 16 |
| EG001 | 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. Chlorthalidone: Chlorthalidone Bumetanide: Bumetanide | 0 | 16 | 1 | 16 | 11 | 16 |
|
|
| Hyponatremia | Renal and urinary disorders | Systematic Assessment | Seric sodium less than 129 meq / liter |
|
| hypokalemia | Renal and urinary disorders | Systematic Assessment | Seric potassium less than 3.5 meq/litre |
|
| hyperuricemia | Renal and urinary disorders | Systematic Assessment | Seric uric acid greater than 8 mg/dl |
|
Not provided
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001577 | Benzophenones |
| D010797 | Phthalimides |
| D007094 | Imides |
| D007659 | Ketones |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| Lupus |
|
| Unknown |
|