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临床试验/NCT03923933
NCT03923933已完成2 期

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

Hospital General de México Dr. Eduardo Liceaga1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年6月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
34
试验地点
1
主要终点
Change in Total Body Water

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Allergies known to diuretics
  • Patients with severe infections
  • Patients with hemodynamic instability
  • Patients with cognitive impairment
  • Patients with acute renal failure
  • Patients with graft loss

研究组 & 干预措施

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.

干预措施: Bumetanide (Drug)

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.

干预措施: Chlorthalidone (Drug)

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.

干预措施: Bumetanide (Drug)

结局指标

主要结局

Change in Total Body Water

时间窗: Change from Basal to day 28

Measured by bioelectrical impedance analysis, compared to the initial measurement

次要结局

  • Change in the Fractional Excretion of Sodium(Change from Basal to day 28)
  • Change in Extracellular Water(Change from Basal to day 28)
  • Change in Extracellular Water / Total Body Water Ratio(Change from Basal to day 28)
  • Change in Systolic Blood Pressure(Change from Basal to day 28)
  • Change in Mean Arterial Pressure(Change from Basal to day 28)
  • Change in Diastolic Blood Pressure(Change from Basal to day 28)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Fabio Solis-Jimenez

Principal Investigator

Hospital General de México Dr. Eduardo Liceaga

研究点 (1)

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