Abstract：
BACKGROUND: The co-administration of loop diuretics with thiazide diuretics is a therapeutic strategy in patients with hypertension and volume overload. The aim of this study was to assess the efficacy and safety of treatment with bumetanide plus chlorthalidone in patients with chronic kidney disease (CKD) stage 4-5 KDIGO.
METHODS: A double-blind randomized study was conducted. Patients were randomized into two groups: bumetanide plus chlorthalidone group (intervention) and the bumetanide plus placebo group (control) to evaluate differences in TBW, ECW and ECW/TBW between baseline and 30 Days of follow-up. Volume overload was defined as \'bioelectrical impedance analysis as fluid volume above the 90th percentile of a presumed healthy reference population. The study\'s registration number was NCT03923933.
RESULTS: Thirty-two patients with a mean age of 57.2 ± 9.34 years and a median estimated glomerular filtration rate (eGFR) of 16.7 ml/min/1.73 m2 (2.2-29) were included. There was decreased volume overload in the liters of total body water (TBW) on Day 7 (intervention: -2.5 vs. control: -0.59, p = 0.003) and Day 30 (intervention: -5.3 vs. control: -0.07, p = 0.016); and in liters of extracellular water (ECW) on Day 7 (intervention: -1.58 vs. control: -0.43, p < 0.001) and Day 30 (intervention: -3.05 vs. control: -0.15, p < 0.000). There was also a decrease in systolic blood pressure on Day 7 (intervention: -18 vs. control: -7.5, p = 0.073) and Day 30 (intervention: -26.1 vs. control: -10, p = 0.028) and in diastolic blood pressure on Day 7 (intervention: -8.5 vs. control: -2.25, p = 0.059) and Day 30 (intervention: -13.5 vs. control: -3.4, p = 0.018).
CONCLUSIONS: In CKD stage 4-5 KDIGO without renal replacement therapy, bumetanide in combination with chlorthalidone is more effective in treating volume overload and hypertension than bumetanide with placebo.
METHODS: A double-blind randomized study was conducted. Patients were randomized into two groups: bumetanide plus chlorthalidone group (intervention) and the bumetanide plus placebo group (control) to evaluate differences in TBW, ECW and ECW/TBW between baseline and 30 Days of follow-up. Volume overload was defined as \'bioelectrical impedance analysis as fluid volume above the 90th percentile of a presumed healthy reference population. The study\'s registration number was NCT03923933.
RESULTS: Thirty-two patients with a mean age of 57.2 ± 9.34 years and a median estimated glomerular filtration rate (eGFR) of 16.7 ml/min/1.73 m2 (2.2-29) were included. There was decreased volume overload in the liters of total body water (TBW) on Day 7 (intervention: -2.5 vs. control: -0.59, p = 0.003) and Day 30 (intervention: -5.3 vs. control: -0.07, p = 0.016); and in liters of extracellular water (ECW) on Day 7 (intervention: -1.58 vs. control: -0.43, p < 0.001) and Day 30 (intervention: -3.05 vs. control: -0.15, p < 0.000). There was also a decrease in systolic blood pressure on Day 7 (intervention: -18 vs. control: -7.5, p = 0.073) and Day 30 (intervention: -26.1 vs. control: -10, p = 0.028) and in diastolic blood pressure on Day 7 (intervention: -8.5 vs. control: -2.25, p = 0.059) and Day 30 (intervention: -13.5 vs. control: -3.4, p = 0.018).
CONCLUSIONS: In CKD stage 4-5 KDIGO without renal replacement therapy, bumetanide in combination with chlorthalidone is more effective in treating volume overload and hypertension than bumetanide with placebo.
摘要：
背景：环型利尿剂与噻嗪类利尿剂共同给药是高血压和容量超负荷患者的一种治疗策略。这项研究的目的是评估布美他尼联合氯噻酮治疗慢性肾脏病（CKD）4-5KDIGO患者的疗效和安全性。
方法：进行双盲随机研究。患者被随机分为两组：布美他尼加氯噻酮组（干预）和布美他尼加安慰剂组（对照组），以评估TBW的差异。基线和随访30天之间的ECW和ECW/TBW。体积超负荷定义为生物电阻抗分析，即假定健康参考人群的第90百分位数以上的液体体积。该研究的注册号为NCT03923933。
结果：纳入32例患者，平均年龄为57.2±9.34岁，肾小球滤过率（eGFR）中位数为16.7ml/min/1.73m2（2.2-29）。第7天全身水（TBW）的升容量超负荷减少（干预：-2.5vs.对照：-0.59，p=0.003）和第30天（干预：-5.3vs.对照：-0.07，p=0.016）；第7天的细胞外水（ECW）升数（干预：-1.58vs.对照：-0.43，p<0.001）和第30天（干预：-3.05vs.控制：-0.15，p<0.000）。第7天收缩压也降低（干预：-18vs.控制：-7.5，p=0.073）和第30天（干预：-26.1vs.控制：-10，p=0.028）和第7天的舒张压（干预：-8.5vs.控制：-2.25，p=0.059）和第30天（干预：-13.5vs.控制：-3.4，p=0.018）。
结论：在没有肾脏替代治疗的CKD4-5期KDIGO中，布美他尼与氯噻酮联合治疗容量超负荷和高血压比安慰剂更有效。
方法：进行双盲随机研究。患者被随机分为两组：布美他尼加氯噻酮组（干预）和布美他尼加安慰剂组（对照组），以评估TBW的差异。基线和随访30天之间的ECW和ECW/TBW。体积超负荷定义为生物电阻抗分析，即假定健康参考人群的第90百分位数以上的液体体积。该研究的注册号为NCT03923933。
结果：纳入32例患者，平均年龄为57.2±9.34岁，肾小球滤过率（eGFR）中位数为16.7ml/min/1.73m2（2.2-29）。第7天全身水（TBW）的升容量超负荷减少（干预：-2.5vs.对照：-0.59，p=0.003）和第30天（干预：-5.3vs.对照：-0.07，p=0.016）；第7天的细胞外水（ECW）升数（干预：-1.58vs.对照：-0.43，p<0.001）和第30天（干预：-3.05vs.控制：-0.15，p<0.000）。第7天收缩压也降低（干预：-18vs.控制：-7.5，p=0.073）和第30天（干预：-26.1vs.控制：-10，p=0.028）和第7天的舒张压（干预：-8.5vs.控制：-2.25，p=0.059）和第30天（干预：-13.5vs.控制：-3.4，p=0.018）。
结论：在没有肾脏替代治疗的CKD4-5期KDIGO中，布美他尼与氯噻酮联合治疗容量超负荷和高血压比安慰剂更有效。
