TY - JOUR
T1 - A randomized multicenter trial on a lung ultrasound-guided treatment strategy in patients on chronic hemodialysis with high cardiovascular risk
AU - Zoccali, Carmine
AU - Torino, Claudia
AU - Mallamaci, Francesca
AU - Sarafidis, Pantelis
AU - Papagianni, Aikaterini
AU - Ekart, Robert
AU - Hojs, Radovan
AU - Klinger, Marian
AU - Letachowicz, Krzysztof
AU - Fliser, Danilo
AU - Seiler-Mußler, Sarah
AU - Lizzi, Fabio
AU - Wiecek, Andrzej
AU - Miskiewicz, Agata
AU - Siamopoulos, Kostas
AU - Balafa, Olga
AU - Slotki, Itzchak
AU - Shavit, Linda
AU - Stavroulopoulos, Aristeidis
AU - Covic, Adrian
AU - Siriopol, Dimitrie
AU - Massy, Ziad A.
AU - Seidowsky, Alexandre
AU - Battaglia, Yuri
AU - Martinez-Castelao, Alberto
AU - Polo-Torcal, Carolina
AU - Coudert-Krier, Marie-Jeanne
AU - Rossignol, Patrick
AU - Fiaccadori, Enrico
AU - Regolisti, Giuseppe
AU - Hannedouche, Thierry
AU - Bachelet, Thomas
AU - Jager, Kitty J.
AU - Dekker, Friedo W.
AU - Tripepi, Rocco
AU - Tripepi, Giovanni
AU - Gargani, Luna
AU - Sicari, Rosa
AU - Picano, Eugenio
AU - London, G. rard Michel
N1 - Funding Information:
The authors are members of the EURECAm working group of the ERA-EDTA and the LUST trial was funded in 2013 by a grant of the ERA-EDTA (no number for the grant is available). We thank the following clinicians (nephrologists and cardiologists) for their collaboration in the LUST trial: Eric Abergel (Bordeaux, France); Jawad Atrash (Jerusalem, Israel); Caroline Bidault (Paris, France); Marie Blinn (Homburg/Saar, Germany); Astrid Breitbart (Hannover, Germany); Albane Brodin-Sartorius (Paris, France); Maciej Bulanowski (Katowice, Poland); Carola Cademartiri (Parma, Italy); Loutradis N. Charalampos (Thessaloniki, Greece); Nelly Castin (Nancy, France); Faty Diallo (Paris, France); Paola Di Marco, Eric Prinz (Strasbourg, France); Tommaso Di Motta (Parma, Italy); Philipp Ege (Homburg/Saar, Germany); Andreu Foraster, Alex Ruiz-Mayoral, and Gustavo Villalobos (Barcelona, Spain); Klaudia Gieszczyk-Str?zik (Katowice, Poland); Nicolas Girerd (Nancy, France); Anna Gozdzik (Wroclaw, Poland); Gunnar Henrik Heine (Homburg/Saar, Germany); Barbara Krunic (Maribor, Slovenia); Nicolas Mansecal (Paris, France); Sylvain Marchais (Manh?s, Fleury M?rogis, France); Fran?ois Marchal (Bordeaux, France); Edoardo Melilli (Barcelona, Spain); Katarzyna Mizia (Katowice, Poland); Mihai Onofriescu (Iasi, Romania); Bruno Marc Pannier (Manh?s, Fleury M?rogis, France); Konstantinos Pappas (Ioannina, Greece); Carolina Polo (Barcelona, Spain); Giuseppe Regolisti (Parma, Italy); Radu Andy Sascau (Iasi, Romania); Franco Schito (Parma, Italy); Alexandre Seidowsky (Paris, France); Tomas Serrato (Manh?s, Fleury M?rogis, France); Linda Shavit (Jerusalem, Israel); Sophie Vallance (Nancy, France); Eve Vilaine (Paris, France); Gustavo Villalobos (Barcelona, Spain); Tanya Weitsman (Jerusalem, Israel); Stephen Zewinger (Homburg/Saar, Germany); and Christos Zounis (Kallithea, Greece). We thank the independent Data Safety Monitoring Committee members: Dr. Michel Kessler (nephrologist, Nancy, France); Renaud Fay (statistician, Nancy, France); Michele Emdin (cardiologist, Pisa, Italy); Dr. Yohann Bernard and Nadine Petitpain of the Nancy Regional and University Hospital Center, which sponsored the trial in the French centers; and Dr. Xavier Lepage of the Nancy Centre d'Investigation Clinique.
Publisher Copyright:
© 2021
PY - 2021/12
Y1 - 2021/12
N2 - 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.
AB - 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.
KW - ESRD
KW - cardiovascular risk
KW - chronic kidney failure
KW - heart failure hemodialysis
KW - lung congestion
KW - lung ultrasound
UR - https://www.scopus.com/pages/publications/85115173658
U2 - 10.1016/j.kint.2021.07.024
DO - 10.1016/j.kint.2021.07.024
M3 - Article
C2 - 34418415
SN - 0085-2538
VL - 100
SP - 1325
EP - 1333
JO - Kidney international
JF - Kidney international
IS - 6
ER -