Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
152 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-03-14
Study Completion Date
2025-06-30
Brief Summary
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Background: Incremental hemodialysis (HD) is a starting regime for renal replacement therapy (RRT) adapted to each patient's necessities. It is mainly conditioned by the residual renal function (RRF). The frequency of sessions with which patients start HD -one or two sessions per week-, is lower than that for conventional HD three times per week. Such frequency is increased (from one to two sessions, and from two to three sessions) as the RRF declines.
Methods/Design: IHDIP is a multicenter randomized 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 patients older than 18 years with chronic renal disease stage 5 and start HD as RRT, 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 one session of HD per week (incremental HD). The control group includes 76 patients who will start with three sessions per week (conventional HD). The primary purpose is assessing the survival rate, while the secondary purposes are the morbidity rate (hospital admissions), the clinical parameters, the quality of life and the efficiency.
Discussion: This study will enable us to know with the highest level of scientific evidence, the number of sessions a patient should receive when starting the HD treatment, depending on his/her RRF.
Methods/Design: IHDIP is a multicenter randomized 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 patients older than 18 years with chronic renal disease stage 5 and start HD as RRT, 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 one session of HD per week (incremental HD). The control group includes 76 patients who will start with three sessions per week (conventional HD). The primary purpose is assessing the survival rate, while the secondary purposes are the morbidity rate (hospital admissions), the clinical parameters, the quality of life and the efficiency.
Discussion: This study will enable us to know with the highest level of scientific evidence, the number of sessions a patient should receive when starting the HD treatment, depending on his/her RRF.
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Detailed Description
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Conventional thrice-weekly HD for 3 to 5 hours in a health center in an outpatient basis is the most used renal replacement therapy (RRT) regimen (1). However, it has an unacceptable high mortality rate (10%-20% a year). In order to try to improve those results, new regimens have been proposed. They are based on an increase of the HD dose and/or a higher number of sessions (2). Nevertheless, inconsistent results in terms of clinical benefits with such programs have been shown in recently published randomized and controlled trials (3,4), together with a lower rate of vascular access success (5) and a lower maintenance of the RRF (6) The National Kidney Foundation-Kidney Disease Outcomes Quality Initiate (NKD KDOQI 2015)(1) 2015 guidelines allow the reduction in the weekly HD dose for patients with a residual kidney urea clearance (KrU) higher than 3ml/min/1.73m2. In these cases, the renal clearance (Kr) is added to the dialysis clearance (Kd) obtained in 2 sessions per week, thus obtaining the adequate dialysis dose (7,8) Surprisingly enough, few centers follow this recommendation when over 50% of patients start HD with KrU \>3 mL/min (9).
Authors like Kalantar-Zadeh et al (9,10) in the U.S.A. or Teruel et al (11) in Spain have published their experience with 2 HD sessions per week in incident patients. Through this regime they have shown that the RRF is preserved and the survival rate is similar to the one obtained with the conventional HD. This is due to the fact that the Kr has much greater clinical weight than Kd7, since the RRF contributes to the production of vitamin D and erythropoietine (12,13), and eliminates the protein-bound uremic toxins that are poorly dialyzed (13,14). In other words, the RRF plays a fundamental role both in the dialysis adequacy and in survival (15,16).
Currently, some authors are questioning the number of HD sessions with which a patient should start the renal replacement therapy (RRT) (7, 17-19). Progressive HD is an initiation regimen adapted to the patient's RRF. The frequency increases as the daily diuretic level declines (7, 17-19).
The IHDIP trial20 aims at determining whether or not starting with one HD session per week reduces mortality in incident patients and its influence in morbidity (hospital admissions), clinical parameters, quality of life and efficiency with regard to the patients who start RRT with the conventional method.
Authors like Kalantar-Zadeh et al (9,10) in the U.S.A. or Teruel et al (11) in Spain have published their experience with 2 HD sessions per week in incident patients. Through this regime they have shown that the RRF is preserved and the survival rate is similar to the one obtained with the conventional HD. This is due to the fact that the Kr has much greater clinical weight than Kd7, since the RRF contributes to the production of vitamin D and erythropoietine (12,13), and eliminates the protein-bound uremic toxins that are poorly dialyzed (13,14). In other words, the RRF plays a fundamental role both in the dialysis adequacy and in survival (15,16).
Currently, some authors are questioning the number of HD sessions with which a patient should start the renal replacement therapy (RRT) (7, 17-19). Progressive HD is an initiation regimen adapted to the patient's RRF. The frequency increases as the daily diuretic level declines (7, 17-19).
The IHDIP trial20 aims at determining whether or not starting with one HD session per week reduces mortality in incident patients and its influence in morbidity (hospital admissions), clinical parameters, quality of life and efficiency with regard to the patients who start RRT with the conventional method.
Conditions
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Renal Disease, End-Stage
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
This is a prospective, multicenter, randomized clinical trial. It has two strata: for age (≥or\< 75 years old) and for KrU (≥or\< 5,5 ml/min/1.73m2). It is controlled through usual clinical practice.
Intervention consists in reducing the frequency or number of sessions per week with which patients start the HD treatment. The experimental group will start with one session/week, then the number of weekly sessions will be increased to two and later to three as per criteria for progression.
Intervention consists in reducing the frequency or number of sessions per week with which patients start the HD treatment. The experimental group will start with one session/week, then the number of weekly sessions will be increased to two and later to three as per criteria for progression.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Experimental group
76 patients who start RRT with the incremental HD regimen.
Group Type
EXPERIMENTAL
Incremental haemodialysis
Intervention Type
PROCEDURE
It consists in reducing the frequency or number of sessions per week with which patients start the HD treatment. The experimental group will start with one session/week, then the number of weekly sessions will be increased to two and later to three as per criteria for progression
Control group
76 patients who start RRT with the conventional HD (3 sessions per week)
Group Type
ACTIVE_COMPARATOR
Conventional haemodialysis
Intervention Type
PROCEDURE
It is controlled through usual clinical practice, based on starting the HD treatment with three sessions per week (control group).
Interventions
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Incremental haemodialysis
It consists in reducing the frequency or number of sessions per week with which patients start the HD treatment. The experimental group will start with one session/week, then the number of weekly sessions will be increased to two and later to three as per criteria for progression
Intervention Type
PROCEDURE
Conventional haemodialysis
It is controlled through usual clinical practice, based on starting the HD treatment with three sessions per week (control group).
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* Adults aged \>18 years, incident patients with stage 5 CKD who have chosen HD as RRT initiation.
* RRF measured by KrU ≥ 4 ml/min/1.73m2. In general, it is advised not to start HD with a KrU\> 7.
* Informed consent signed before starting any activity related to the trial.
* RRF measured by KrU ≥ 4 ml/min/1.73m2. In general, it is advised not to start HD with a KrU\> 7.
* Informed consent signed before starting any activity related to the trial.
Exclusion Criteria
* Unplanned HD initiation (established in point 7.4 of the protocol)
* Non incident patients, in other words, patients who were previously on RRT, either on peritoneal dialysis, or on kidney transplant.
* Active neoplasia at the moment of inclusion
* Cardiovascular disease defined as: heart failure type IV of the New York Heart Association (NYHA), unstable angina or ischemic cardiopathy which has caused any admission in hospital in the last 3 months.
* Cardiorenal syndrome
* Active inflammatory disease with immunosuppressive treatment
* Hepatorenal syndrome
* Non incident patients, in other words, patients who were previously on RRT, either on peritoneal dialysis, or on kidney transplant.
* Active neoplasia at the moment of inclusion
* Cardiovascular disease defined as: heart failure type IV of the New York Heart Association (NYHA), unstable angina or ischemic cardiopathy which has caused any admission in hospital in the last 3 months.
* Cardiorenal syndrome
* Active inflammatory disease with immunosuppressive treatment
* Hepatorenal syndrome
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hospital Arquitecto Marcide. Ferrol. A Coruña. (Spain)
UNKNOWN
Sponsor Role
collaborator
Hospital San Pedro de Alcantara
OTHER
Sponsor Role
collaborator
Virgen del Puerto Hospital
OTHER
Sponsor Role
collaborator
Hospital Central de la Defensa Gómez Ulla. Madrid (Spain)
UNKNOWN
Sponsor Role
collaborator
Hospital Costa del Sol
OTHER
Sponsor Role
collaborator
Hospital Obispo Polanco. Teruel (Spain)
UNKNOWN
Sponsor Role
collaborator
Hospital de Manises. Valencia (Spain)
UNKNOWN
Sponsor Role
collaborator
Hospital Virgen de la Concha. Zamora (Spain)
UNKNOWN
Sponsor Role
collaborator
Hospital de Especialidades de las Fuerzas Armadas. Quito (Ecuador)
UNKNOWN
Sponsor Role
collaborator
Servicio Extremeño de Salud (Spain)
UNKNOWN
Sponsor Role
collaborator
Hospital del SAS de Jerez
OTHER
Sponsor Role
collaborator
Hospital Nuestra Sra de Sonsoles. Ávila (Spain)
UNKNOWN
Sponsor Role
collaborator
Dialysis Center SM2. Potenza (Italy)
UNKNOWN
Sponsor Role
collaborator
Miulli General Hospital
OTHER
Sponsor Role
collaborator
Hospital del Rio Hortega
OTHER
Sponsor Role
collaborator
Hospital Duran de Buenos Aires
UNKNOWN
Sponsor Role
collaborator
Hospital El Bierzo
OTHER
Sponsor Role
collaborator
Hospitales Universitarios Virgen del Rocío
OTHER
Sponsor Role
collaborator
Hospital Universitario Virgen Macarena
OTHER
Sponsor Role
collaborator
University Hospital of Girona Dr. Josep Trueta
NETWORK
Sponsor Role
collaborator
Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Javier L Deira Lorenzo, PhD MD
Role: PRINCIPAL_INVESTIGATOR
Servicio Extremeño de Salud
Miguel A Suarez Santisteban, MD
Role: PRINCIPAL_INVESTIGATOR
Servicio Extremeño de Salud
Locations
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FundeSalud. Junta de Extremadura
Mérida, Badajoz, Spain
Site Status
Hospital Virgen del Puerto
Plasencia, Cáceres, Spain
Site Status
Hospital San Pedro de Alcántara
Cáceres, , Spain
Site Status
Countries
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Spain
References
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National Kidney Foundation. KDOQI Clinical Practice Guideline for Hemodialysis Adequacy: 2015 update. Am J Kidney Dis. 2015 Nov;66(5):884-930. doi: 10.1053/j.ajkd.2015.07.015.
Reference Type
BACKGROUND
Chan CT, Covic A, Craig JC, Davenport A, Kasiske BL, Kuhlmann MK, Levin NW, Li PK, Locatelli F, Rocco MV, Wheeler DC. Novel techniques and innovation in blood purification: a clinical update from Kidney Disease: Improving Global Outcomes. Kidney Int. 2013 Mar;83(3):359-71. doi: 10.1038/ki.2012.450. Epub 2013 Jan 16.
Reference Type
BACKGROUND
Chertow GM, Levin NW, Beck GJ, Daugirdas JT, Eggers PW, Kliger AS, Larive B, Rocco MV, Greene T; Frequent Hemodialysis Network (FHN) Trials Group. Long-Term Effects of Frequent In-Center Hemodialysis. J Am Soc Nephrol. 2016 Jun;27(6):1830-6. doi: 10.1681/ASN.2015040426. Epub 2015 Oct 14.
Reference Type
BACKGROUND
Rocco MV, Daugirdas JT, Greene T, Lockridge RS, Chan C, Pierratos A, Lindsay R, Larive B, Chertow GM, Beck GJ, Eggers PW, Kliger AS; FHN Trial Group. Long-term Effects of Frequent Nocturnal Hemodialysis on Mortality: The Frequent Hemodialysis Network (FHN) Nocturnal Trial. Am J Kidney Dis. 2015 Sep;66(3):459-68. doi: 10.1053/j.ajkd.2015.02.331. Epub 2015 Apr 8.
Reference Type
BACKGROUND
Suri RS, Larive B, Sherer S, Eggers P, Gassman J, James SH, Lindsay RM, Lockridge RS, Ornt DB, Rocco MV, Ting GO, Kliger AS; Frequent Hemodialysis Network Trial Group. Risk of vascular access complications with frequent hemodialysis. J Am Soc Nephrol. 2013 Feb;24(3):498-505. doi: 10.1681/ASN.2012060595. Epub 2013 Feb 7.
Reference Type
BACKGROUND
Daugirdas JT, Greene T, Rocco MV, Kaysen GA, Depner TA, Levin NW, Chertow GM, Ornt DB, Raimann JG, Larive B, Kliger AS; FHN Trial Group. Effect of frequent hemodialysis on residual kidney function. Kidney Int. 2013 May;83(5):949-58. doi: 10.1038/ki.2012.457. Epub 2013 Jan 23.
Reference Type
BACKGROUND
Clark EG, Bagshaw SM. Unnecessary renal replacement therapy for acute kidney injury is harmful for renal recovery. Semin Dial. 2015 Jan-Feb;28(1):6-11. doi: 10.1111/sdi.12300. Epub 2014 Oct 30.
Reference Type
BACKGROUND
Mathew AT, Fishbane S, Obi Y, Kalantar-Zadeh K. Preservation of residual kidney function in hemodialysis patients: reviving an old concept. Kidney Int. 2016 Aug;90(2):262-271. doi: 10.1016/j.kint.2016.02.037. Epub 2016 May 12.
Reference Type
BACKGROUND
Patel N, Hu SL. Preserving residual renal function in dialysis: what we know. Semin Dial. 2015 May-Jun;28(3):250-8. doi: 10.1111/sdi.12302. Epub 2014 Sep 18.
Reference Type
BACKGROUND
Casino FG, Basile C. The variable target model: a paradigm shift in the incremental haemodialysis prescription. Nephrol Dial Transplant. 2017 Jan 1;32(1):182-190. doi: 10.1093/ndt/gfw339.
Reference Type
BACKGROUND
Shafi T, Jaar BG, Plantinga LC, Fink NE, Sadler JH, Parekh RS, Powe NR, Coresh J. Association of residual urine output with mortality, quality of life, and inflammation in incident hemodialysis patients: the Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) Study. Am J Kidney Dis. 2010 Aug;56(2):348-58. doi: 10.1053/j.ajkd.2010.03.020. Epub 2010 Jun 3.
Reference Type
BACKGROUND
van der Wal WM, Noordzij M, Dekker FW, Boeschoten EW, Krediet RT, Korevaar JC, Geskus RB; Netherlands Cooperative Study on the Adequacy of Dialysis Study Group (NECOSAD). Full loss of residual renal function causes higher mortality in dialysis patients; findings from a marginal structural model. Nephrol Dial Transplant. 2011 Sep;26(9):2978-83. doi: 10.1093/ndt/gfq856. Epub 2011 Feb 11.
Reference Type
BACKGROUND
Obi Y, Streja E, Rhee CM, Ravel V, Amin AN, Cupisti A, Chen J, Mathew AT, Kovesdy CP, Mehrotra R, Kalantar-Zadeh K. Incremental Hemodialysis, Residual Kidney Function, and Mortality Risk in Incident Dialysis Patients: A Cohort Study. Am J Kidney Dis. 2016 Aug;68(2):256-265. doi: 10.1053/j.ajkd.2016.01.008. Epub 2016 Feb 9.
Reference Type
BACKGROUND
Wong J, Vilar E, Davenport A, Farrington K. Incremental haemodialysis. Nephrol Dial Transplant. 2015 Oct;30(10):1639-48. doi: 10.1093/ndt/gfv231. Epub 2015 Jun 1.
Reference Type
BACKGROUND
Termorshuizen F, Dekker FW, van Manen JG, Korevaar JC, Boeschoten EW, Krediet RT; NECOSAD Study Group. Relative contribution of residual renal function and different measures of adequacy to survival in hemodialysis patients: an analysis of the Netherlands Cooperative Study on the Adequacy of Dialysis (NECOSAD)-2. J Am Soc Nephrol. 2004 Apr;15(4):1061-70. doi: 10.1097/01.asn.0000117976.29592.93.
Reference Type
BACKGROUND
Vilar E, Wellsted D, Chandna SM, Greenwood RN, Farrington K. Residual renal function improves outcome in incremental haemodialysis despite reduced dialysis dose. Nephrol Dial Transplant. 2009 Aug;24(8):2502-10. doi: 10.1093/ndt/gfp071. Epub 2009 Feb 24.
Reference Type
BACKGROUND
Zhang M, Wang M, Li H, Yu P, Yuan L, Hao C, Chen J, Kalantar-Zadeh K. Association of initial twice-weekly hemodialysis treatment with preservation of residual kidney function in ESRD patients. Am J Nephrol. 2014;40(2):140-50. doi: 10.1159/000365819. Epub 2014 Aug 23.
Reference Type
BACKGROUND
Fernandez Lucas M, Teruel JL. Incremental hemodialysis schedule at the start of renal replacement therapy. Nefrologia. 2017 Jan-Feb;37(1):1-4. doi: 10.1016/j.nefro.2016.08.002. Epub 2016 Oct 1. No abstract available. English, Spanish.
Reference Type
BACKGROUND
Toth-Manikowski SM, Shafi T. Hemodialysis Prescription for Incident Patients: Twice Seems Nice, But Is It Incremental? Am J Kidney Dis. 2016 Aug;68(2):180-183. doi: 10.1053/j.ajkd.2016.04.005. No abstract available.
Reference Type
BACKGROUND
Caria S, Cupisti A, Sau G, Bolasco P. The incremental treatment of ESRD: a low-protein diet combined with weekly hemodialysis may be beneficial for selected patients. BMC Nephrol. 2014 Oct 29;15:172. doi: 10.1186/1471-2369-15-172.
Reference Type
BACKGROUND
Bolasco P, Cupisti A, Locatelli F, Caria S, Kalantar-Zadeh K. Dietary Management of Incremental Transition to Dialysis Therapy: Once-Weekly Hemodialysis Combined With Low-Protein Diet. J Ren Nutr. 2016 Nov;26(6):352-359. doi: 10.1053/j.jrn.2016.01.015. Epub 2016 Feb 28.
Reference Type
BACKGROUND
Libetta C, Esposito P, Dal Canton A. Once-weekly hemodialysis: a single-center experience. Am J Kidney Dis. 2015 Feb;65(2):343. doi: 10.1053/j.ajkd.2014.07.034. No abstract available.
Reference Type
BACKGROUND
Parra Moncasi E, Arenas Jimenez MD, Alonso M, Martinez MF, Gamen Pardo A, Rebollo P, Ortega Montoliu T, Martinez Terrer T, Alvarez-Ude F; Grupo de Gestion de la Calidad de la Sociedad Espanola de Nefrologia. Multicentre study of haemodialysis costs. Nefrologia. 2011;31(3):299-307. doi: 10.3265/Nefrologia.pre2011.Apr.10813. English, Spanish.
Reference Type
BACKGROUND
Deira J, Suarez MA, Lopez F, Garcia-Cabrera E, Gascon A, Torregrosa E, Garcia GE, Huertas J, de la Flor JC, Puello S, Gomez-Raja J, Grande J, Lerma JL, Corradino C, Musso C, Ramos M, Martin J, Basile C, Casino FG. IHDIP: a controlled randomized trial to assess the security and effectiveness of the incremental hemodialysis in incident patients. BMC Nephrol. 2019 Jan 9;20(1):8. doi: 10.1186/s12882-018-1189-6.
Reference Type
DERIVED
Suarez MA, Garcia-Cabrera E, Gascon A, Lopez F, Torregrosa E, Garcia GE, Huertas J, de la Flor JC, Puello S, Gomez-Raja J, Grande J, Lerma JL, Corradino C, Ramos M, Martin J, Basile C, Casino FG, Deira J. Rationale and design of DiPPI: A randomized controlled trial to evaluate the safety and effectiveness of progressive hemodialysis in incident patients. Nefrologia (Engl Ed). 2018 Nov-Dec;38(6):630-638. doi: 10.1016/j.nefro.2018.07.010. Epub 2018 Oct 19. English, Spanish.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IHDIP (P1712)
Identifier Type: -
Identifier Source: org_study_id
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