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A randomized multicenter trial on a lung ultrasound–guided treatment strategy in patients on chronic hemodialysis with high cardiovascular risk
Kidney International ( IF 14.8 ) Pub Date : 2021-08-19 , DOI: 10.1016/j.kint.2021.07.024
Carmine Zoccali 1 , Claudia Torino 2 , Francesca Mallamaci 2 , Pantelis Sarafidis 3 , Aikaterini Papagianni 3 , Robert Ekart 4 , Radovan Hojs 4 , Marian Klinger 5 , Krzysztof Letachowicz 6 , Danilo Fliser 7 , Sarah Seiler-Mußler 7 , Fabio Lizzi 7 , Andrzej Wiecek 8 , Agata Miskiewicz 8 , Kostas Siamopoulos 9 , Olga Balafa 9 , Itzchak Slotki 10 , Linda Shavit 10 , Aristeidis Stavroulopoulos 11 , Adrian Covic 12 , Dimitrie Siriopol 12 , Ziad A Massy 13 , Alexandre Seidowsky 13 , Yuri Battaglia 14 , Alberto Martinez-Castelao 15 , Carolina Polo-Torcal 15 , Marie-Jeanne Coudert-Krier 16 , Patrick Rossignol 17 , Enrico Fiaccadori 18 , Giuseppe Regolisti 18 , Thierry Hannedouche 19 , Thomas Bachelet 20 , Kitty J Jager 21 , Friedo W Dekker 22 , Rocco Tripepi 2 , Giovanni Tripepi 2 , Luna Gargani 23 , Rosa Sicari 23 , Eugenio Picano 23 , Gérard Michel London 24
Affiliation  

Lung congestion is a risk factor for all-cause and cardiovascular mortality in patients on chronic hemodialysis, and its estimation by ultrasound may be useful to guide ultrafiltration and drug therapy in this population. In an international, multi-center randomized controlled trial (NCT02310061) we investigated whether a lung ultrasound-guided treatment strategy improved a composite end point (all-cause death, non-fatal myocardial infarction, decompensated heart failure) vs usual care in patients receiving chronic hemodialysis with high cardiovascular risk. Patient-Reported Outcomes (Depression and the Standard Form 36 Quality of Life Questionnaire, SF36) were assessed as secondary outcomes. A total of 367 patients were enrolled: 183 in the active arm and 180 in the control arm. In the active arm, the pre-dialysis lung scan was used to titrate ultrafiltration during dialysis and drug treatment. Three hundred and seven patients completed the study: 152 in the active arm and 155 in the control arm. During a mean follow-up of 1.49 years, lung congestion was significantly more frequently relieved in the active (78%) than in the control (56%) arm and the intervention was safe. The primary composite end point did not significantly differ between the two study arms (Hazard Ratio 0.88; 95% Confidence Interval: 0.63-1.24). The risk for all-cause and cardiovascular hospitalization and the changes of left ventricular mass and function did not differ among the two groups. A post hoc analysis for recurrent episodes of decompensated heart failure (0.37; 0.15-0.93) and cardiovascular events (0.63; 0.41-0.97) showed a risk reduction for these outcomes in the active arm. There were no differences in patient-reported outcomes between groups. Thus, in patients on chronic hemodialysis with high cardiovascular risk, a treatment strategy guided by lung ultrasound effectively relieved lung congestion but was not more effective than usual care in improving the primary or secondary end points of the trial.



中文翻译:

一项关于肺部超声引导治疗策略对心血管高风险慢性血液透析患者的随机多中心试验

肺充血是慢性血液透析患者全因和心血管死亡的危险因素,通过超声估计其可能有助于指导该人群的超滤和药物治疗。在一项国际多中心随机对照试验 (NCT02310061) 中,我们调查了肺部超声引导的治疗策略是否改善了接受治疗的患者的复合终点(全因死亡、非致命性心肌梗死、失代偿性心力衰竭)与常规治疗具有高心血管风险的慢性血液透析。患者报告的结果(抑郁症和标准表格 36 生活质量问卷,SF36)被评估为次要结果。共招募了 367 名患者:活动组 183 名,对照组 180 名。在主动臂中,透析前肺扫描用于滴定透析和药物治疗期间的超滤。307 名患者完成了研究:152 名在活动组中,155 名在对照组中。在平均 1.49 年的随访期间,与对照组 (56%) 相比,活动组 (78%) 的肺充血得到明显缓解,并且干预是安全的。两个研究组的主要复合终点没有显着差异(危险比 0.88;95% 置信区间:0.63-1.24)。两组的全因和心血管住院风险以及左心室质量和功能的变化没有差异。一个 在平均 1.49 年的随访期间,与对照组 (56%) 相比,活动组 (78%) 的肺充血得到明显缓解,并且干预是安全的。两个研究组的主要复合终点没有显着差异(危险比 0.88;95% 置信区间:0.63-1.24)。两组的全因和心血管住院风险以及左心室质量和功能的变化没有差异。一个 在平均 1.49 年的随访期间,与对照组 (56%) 相比,活动组 (78%) 的肺充血得到明显缓解,并且干预是安全的。两个研究组的主要复合终点没有显着差异(危险比 0.88;95% 置信区间:0.63-1.24)。两组的全因和心血管住院风险以及左心室质量和功能的变化没有差异。一个 两组的全因和心血管住院风险以及左心室质量和功能的变化没有差异。一个 两组的全因和心血管住院风险以及左心室质量和功能的变化没有差异。一个对失代偿性心力衰竭 (0.37;0.15-0.93) 和心血管事件 (0.63;0.41-0.97) 反复发作的事后分析显示,积极治疗组这些结果的风险降低。两组患者报告的结果没有差异。因此,对于心血管风险高的慢性血液透析患者,肺部超声引导的治疗策略有效缓解了肺充血,但在改善试验的主要或次要终点方面并不比常规治疗更有效。

更新日期:2021-08-19
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