IHDIP: a controlled randomized trial to assess the security and effectiveness of the incremental hemodialysis in incident patients

被引:34
作者
Deira, Javier [1 ]
Suarez, Miguel A. [2 ]
Lopez, Francisca [3 ]
Garcia-Cabrera, Emilio [4 ]
Gascon, Antonio [5 ]
Torregrosa, Eduardo [6 ]
Garcia, Giannina E. [7 ]
Huertas, Jorge [8 ]
de la Flor, Jose C. [9 ]
Puello, Suleya [10 ]
Gomez-Raja, Jonathan [11 ]
Grande, Jesus [12 ]
Lerma, Jose L. [13 ]
Corradino, Carlos [14 ]
Musso, Carlos [14 ]
Ramos, Manuel [15 ]
Martin, Jesus [16 ]
Basile, Carlo [17 ]
Casino, Francesco G. [17 ,18 ]
机构
[1] Hosp San Pedro de Alcantara, Caceres, Spain
[2] Hosp Virgen Del Puerto, Plasencia, Spain
[3] Hosp Costa del Sol, Marbella, Spain
[4] Delos Clin Res Org, Seville, Spain
[5] Hosp Obispo Polanco, Teruel, Spain
[6] Hosp Manises, Valencia, Spain
[7] Hosp Arquitecto Marcide, Ferrol, Spain
[8] Hosp Especialidades Fuerzas Armadas, Quito, Ecuador
[9] Hosp Cent Def Gomez Ulla, Madrid, Spain
[10] Hosp Clin Univ, Santiago De Compostela, Spain
[11] FundeSalud, Merida, Spain
[12] Hosp Virgen Concha, Zamora, Spain
[13] Complejo Asistencial Univ, Salamanca, Spain
[14] Hosp Durand Buenos Aires, Buenos Aires, DF, Argentina
[15] Hosp Jerez, Cadiz, Spain
[16] Hosp Nuestra Sra Sonsoles, Avila, Spain
[17] Miulli Gen Hosp, Div Nephrol, Clin Res Branch, Bari, Italy
[18] Dialysis Ctr SM2, Potenza, Italy
关键词
Once-weekly haemodialysis; Twice-weekly haemodialysis; Incremental haemodialysis progressive hemodialysis; Randomized clinical trial; RESIDUAL RENAL-FUNCTION; KIDNEY-FUNCTION; FREQUENT HEMODIALYSIS; DIALYSIS PATIENTS; MORTALITY; PRESERVATION; EQUATION; ADEQUACY; SOLUTES; START;
D O I
10.1186/s12882-018-1189-6
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
BackgroundMost people who make the transition to renal replacement therapy (RRT) are treated with a fixed dose thrice-weekly hemodialysis reegimen, without considering their residual kidney function (RKF). Recent papers inform us that incremental hemodialysis is associated with preservation of RKF, whenever compared with conventional hemodialysis. The objective of the present controlled randomized trial (RCT) is to determine if start HD with one sessions per week (1-Wk/HD), it is associated with better patient survival and other safety parameters.Methods/designIHDIP is a multicenter RCT experimental open trial. It is randomized in a 1:1 ratio and controlled through usual clinical practice, with a low intervention level and non-commercial. It includes 152 incident patients older than 18years, with a RRF of 4ml/min/1.73m2, measured by renal clearance of urea (KrU). The intervention group includes 76 patients who will start with incremental HD (1-Wk/HD). The control group includes 76 patients who will start with thrice-weekly hemodialysis regimen. The primary outcome is assessing the survival rate, while the secondary outcomes are the morbidity rate, the clinical parameters, the quality of life and the efficiency.DiscussionThis study will enable to know the number of sessions a patient should receive when starting HD, depending on his RRF. The potentially important clinical and financial implications of incremental hemodialysis warrant this RCT.Trial registrationU.S. National Institutes of Health, ClinicalTrials.gov. Number: NCT03239808, completed 13/04/2017. Sponsor: Foundation for Training and Research of Health Professionals of Extremadura.
引用
收藏
页数:8
相关论文
共 36 条
[1]  
[Anonymous], HEM INCR PAC INC IHD
[2]   How to set the stage for a full-fledged clinical trial testing 'incremental haemodialysis' [J].
Casino, Francesco Gaetano ;
Basile, Carlo .
NEPHROLOGY DIALYSIS TRANSPLANTATION, 2018, 33 (07) :1103-1109
[3]   A user-friendly tool for incremental haemodialysis prescription (vol 33, pg 1046, 2018) [J].
Casino, Francesco Gaetano ;
Basile, Carlo .
NEPHROLOGY DIALYSIS TRANSPLANTATION, 2018, 33 (06) :1074-1074
[4]   The variable target model: a paradigm shift in the incremental haemodialysis prescription [J].
Casino, Francesco Gaetano ;
Basile, Carlo .
NEPHROLOGY DIALYSIS TRANSPLANTATION, 2017, 32 (01) :182-190
[5]   Novel techniques and innovation in blood purification: a clinical update from Kidney Disease: Improving Global Outcomes [J].
Chan, Christopher T. ;
Covic, Adrian ;
Craig, Jonathan C. ;
Davenport, Andrew ;
Kasiske, Bertram L. ;
Kuhlmann, Martin K. ;
Levin, Nathan W. ;
Li, Philip K. T. ;
Locatelli, Francesco ;
Rocco, Michael V. ;
Wheeler, David C. .
KIDNEY INTERNATIONAL, 2013, 83 (03) :359-371
[6]   Long-Term Effects of Frequent In-Center Hemodialysis [J].
Chertow, Glenn M. ;
Levin, Nathan W. ;
Beck, Gerald J. ;
Daugirdas, John T. ;
Eggers, Paul W. ;
Kliger, Alan S. ;
Larive, Brett ;
Rocco, Michael V. ;
Greene, Tom .
JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY, 2016, 27 (06) :1830-1836
[7]   A Randomized, Controlled Trial of Early versus Late Initiation of Dialysis [J].
Cooper, Bruce A. ;
Branley, Pauline ;
Bulfone, Liliana ;
Collins, John F. ;
Craig, Jonathan C. ;
Fraenkel, Margaret B. ;
Harris, Anthony ;
Johnson, David W. ;
Kesselhut, Joan ;
Li, Jing Jing ;
Luxton, Grant ;
Pilmore, Andrew ;
Tiller, David J. ;
Harris, David C. ;
Pollock, Carol A. .
NEW ENGLAND JOURNAL OF MEDICINE, 2010, 363 (07) :609-619
[8]   Estimating Time-averaged Serum Urea Nitrogen Concentration during Various Urine Collection Periods: A Prediction Equation for Thrice Weekly and Biweekly Dialysis Schedules [J].
Daugirdas, John T. .
SEMINARS IN DIALYSIS, 2016, 29 (06) :507-509
[9]  
Daugirdas JT, 2015, AM J KIDNEY DIS, V66, P884, DOI 10.1053/j.ajkd.2015.07.015
[10]   Improved equation for estimating single-pool Kt/V at higher dialysis frequencies [J].
Daugirdas, John T. ;
Leypoldt, John Ken ;
Akonur, Alp ;
Greene, Tom ;
Depner, Thomas A. .
NEPHROLOGY DIALYSIS TRANSPLANTATION, 2013, 28 (08) :2156-2160