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.

A randomized multicenter trial on a lung ultrasound–guided treatment strategy in patients on chronic hemodialysis with high cardiovascular risk / Zoccali, C.; Torino, C.; Mallamaci, F.; Sarafidis, P.; Papagianni, A.; Ekart, R.; Hojs, R.; Klinger, M.; Letachowicz, K.; Fliser, D.; Seiler-Mussler, S.; Lizzi, F.; Wiecek, A.; Miskiewicz, A.; Siamopoulos, K.; Balafa, O.; Slotki, I.; Shavit, L.; Stavroulopoulos, A.; Covic, A.; Siriopol, D.; Massy, Z. A.; Seidowsky, A.; Battaglia, Y.; Martinez-Castelao, A.; Polo-Torcal, C.; Coudert-Krier, M. -J.; Rossignol, P.; Fiaccadori, E.; Regolisti, G.; Hannedouche, T.; Bachelet, T.; Jager, K. J.; Dekker, F. W.; Tripepi, R.; Tripepi, G.; Gargani, L.; Sicari, R.; Picano, E.; London, G. M.. - In: KIDNEY INTERNATIONAL. - ISSN 0085-2538. - 100:6(2021), pp. 1325-1333. [10.1016/j.kint.2021.07.024]

A randomized multicenter trial on a lung ultrasound–guided treatment strategy in patients on chronic hemodialysis with high cardiovascular risk

Fiaccadori E.
Data Curation
;
Regolisti G.;
2021

Abstract

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.
A randomized multicenter trial on a lung ultrasound–guided treatment strategy in patients on chronic hemodialysis with high cardiovascular risk / Zoccali, C.; Torino, C.; Mallamaci, F.; Sarafidis, P.; Papagianni, A.; Ekart, R.; Hojs, R.; Klinger, M.; Letachowicz, K.; Fliser, D.; Seiler-Mussler, S.; Lizzi, F.; Wiecek, A.; Miskiewicz, A.; Siamopoulos, K.; Balafa, O.; Slotki, I.; Shavit, L.; Stavroulopoulos, A.; Covic, A.; Siriopol, D.; Massy, Z. A.; Seidowsky, A.; Battaglia, Y.; Martinez-Castelao, A.; Polo-Torcal, C.; Coudert-Krier, M. -J.; Rossignol, P.; Fiaccadori, E.; Regolisti, G.; Hannedouche, T.; Bachelet, T.; Jager, K. J.; Dekker, F. W.; Tripepi, R.; Tripepi, G.; Gargani, L.; Sicari, R.; Picano, E.; London, G. M.. - In: KIDNEY INTERNATIONAL. - ISSN 0085-2538. - 100:6(2021), pp. 1325-1333. [10.1016/j.kint.2021.07.024]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/2905190
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