Dimitrie Siriopol1, Mihai Onofriescu1, Luminita Voroneanu1, Mugurel Apetrii1, Ionut Nistor1, Simona Hogas1, Mehmet Kanbay2, Radu Sascau3, Dragos Scripcariu4, Adrian Covic5. 1. Nephrology Department, Dialysis and Renal Transplant Center, ''Dr. C.I. Parhon'' University Hospital, ''Grigore T. Popa'' University of Medicine and Pharmacy, No. 50 Carol I Blvd., Iasi, Romania. 2. Division of Nephrology, Department of Medicine, Koc University School of Medicine, Istanbul, Turkey. 3. Cardiology Department, ''Dr. George IM Georgescu'' University Hospital, ''Grigore T. Popa'' University of Medicine and Pharmacy, Iasi, Romania. 4. General Surgery Department, Regional Institute of Oncology, ''Grigore T. Popa'' University of Medicine and Pharmacy, Iasi, Romania. 5. Nephrology Department, Dialysis and Renal Transplant Center, ''Dr. C.I. Parhon'' University Hospital, ''Grigore T. Popa'' University of Medicine and Pharmacy, No. 50 Carol I Blvd., Iasi, Romania. accovic@gmail.com.
Abstract
PURPOSE: Fluid overload is associated with adverse outcomes in hemodialysis (HD) patients. The precise assessment of hydration status in HD patients remains a major challenge for nephrologists. Our study aimed to explore whether combining two bedside methods, lung ultrasonography (LUS) and bioimpedance, may provide complementary information to guide treatment in specific HD patients. METHODS: In total, 250 HD patients from two dialysis units were included in this randomized clinical trial. Patients were randomized 1:1 to have a dry weight assessment based on clinical (control) or LUS with bioimpedance in case of clinical hypovolemia (active)-guided protocol. The primary outcome was to assess the difference between the two groups on a composite of all-cause mortality and first cardiovascular event (CVE)-including death, stroke, and myocardial infarction. RESULTS: During a mean follow-up period was 21.3 ± 5.6 months, there were 54 (21.6%) composite events in the entire population. There was a nonsignificant 9% increase in the risk of this outcome in the active arm (HR = 1.09, 95% CI 0.64-1.86, p = 0.75). Similarly, there were no differences between the two groups when analyzing separately the all-cause mortality and CVE outcomes. However, patients in the active arm had a 19% lower relative risk of pre-dialytic dyspnea (rate ratio-0.81, 95% CI 0.68-0.96), but a 26% higher relative risk of intradialytic cramps (rate ratio-1.26, 95% CI 1.16-1.37). CONCLUSIONS: This study shows that a LUS-bioimpedance-guided dry weight adjustment protocol, as compared to clinical evaluation, does not reduce all-cause mortality and/or CVE in HD patients. A fluid management protocol based on bioimpedance with LUS on indication might be a better strategy.
RCT Entities:
PURPOSE: Fluid overload is associated with adverse outcomes in hemodialysis (HD) patients. The precise assessment of hydration status in HDpatients remains a major challenge for nephrologists. Our study aimed to explore whether combining two bedside methods, lung ultrasonography (LUS) and bioimpedance, may provide complementary information to guide treatment in specific HDpatients. METHODS: In total, 250 HDpatients from two dialysis units were included in this randomized clinical trial. Patients were randomized 1:1 to have a dry weight assessment based on clinical (control) or LUS with bioimpedance in case of clinical hypovolemia (active)-guided protocol. The primary outcome was to assess the difference between the two groups on a composite of all-cause mortality and first cardiovascular event (CVE)-including death, stroke, and myocardial infarction. RESULTS: During a mean follow-up period was 21.3 ± 5.6 months, there were 54 (21.6%) composite events in the entire population. There was a nonsignificant 9% increase in the risk of this outcome in the active arm (HR = 1.09, 95% CI 0.64-1.86, p = 0.75). Similarly, there were no differences between the two groups when analyzing separately the all-cause mortality and CVE outcomes. However, patients in the active arm had a 19% lower relative risk of pre-dialytic dyspnea (rate ratio-0.81, 95% CI 0.68-0.96), but a 26% higher relative risk of intradialytic cramps (rate ratio-1.26, 95% CI 1.16-1.37). CONCLUSIONS: This study shows that a LUS-bioimpedance-guided dry weight adjustment protocol, as compared to clinical evaluation, does not reduce all-cause mortality and/or CVE in HDpatients. A fluid management protocol based on bioimpedance with LUS on indication might be a better strategy.
Authors: Glenn M Chertow; Nathan W Levin; Gerald J Beck; Thomas A Depner; Paul W Eggers; Jennifer J Gassman; Irina Gorodetskaya; Tom Greene; Sam James; Brett Larive; Robert M Lindsay; Ravindra L Mehta; Brent Miller; Daniel B Ornt; Sanjay Rajagopalan; Anjay Rastogi; Michael V Rocco; Brigitte Schiller; Olga Sergeyeva; Gerald Schulman; George O Ting; Mark L Unruh; Robert A Star; Alan S Kliger Journal: N Engl J Med Date: 2010-11-20 Impact factor: 91.245
Authors: Manoch Rattanasompattikul; Usama Feroze; Miklos Z Molnar; Ramanath Dukkipati; Csaba P Kovesdy; Allen R Nissenson; Keith C Norris; Joel D Kopple; Kamyar Kalantar-Zadeh Journal: Int Urol Nephrol Date: 2011-11-30 Impact factor: 2.370
Authors: Mihai Onofriescu; Dimitrie Siriopol; Luminita Voroneanu; Simona Hogas; Ionut Nistor; Mugurel Apetrii; Laura Florea; Gabriel Veisa; Irina Mititiuc; Mehmet Kanbay; Radu Sascau; Adrian Covic Journal: PLoS One Date: 2015-08-14 Impact factor: 3.240
Authors: David Naranjo-Hernández; Javier Reina-Tosina; Laura M Roa; Gerardo Barbarov-Rostán; Nuria Aresté-Fosalba; Alfonso Lara-Ruiz; Pilar Cejudo-Ramos; Francisco Ortega-Ruiz Journal: Sensors (Basel) Date: 2019-12-21 Impact factor: 3.576