Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT03474367
Status:
UNKNOWN
Last Update Posted:
2019-10-02
First Post:
2017-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cost-effectiveness of Urgent-start Therapies Hemodialysis and Peritoneal Dialysis
Sponsor:
Organization:
Raw JSON
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The contribution of chronic kidney disease to the global burden of major noncommunicable diseases. Kidney Int. 2012 May;81(10):1044-1045. doi: 10.1038/ki.2012.39. No abstract available.'}, {'pmid': '21422925', 'type': 'BACKGROUND', 'citation': 'Eggers PW. Has the incidence of end-stage renal disease in the USA and other countries stabilized? Curr Opin Nephrol Hypertens. 2011 May;20(3):241-5. doi: 10.1097/MNH.0b013e3283454319.'}, {'pmid': '25157840', 'type': 'BACKGROUND', 'citation': 'Klarenbach SW, Tonelli M, Chui B, Manns BJ. Economic evaluation of dialysis therapies. Nat Rev Nephrol. 2014 Nov;10(11):644-52. doi: 10.1038/nrneph.2014.145. Epub 2014 Aug 26.'}, {'pmid': '21310740', 'type': 'BACKGROUND', 'citation': 'Haller M, Gutjahr G, Kramar R, Harnoncourt F, Oberbauer R. Cost-effectiveness analysis of renal replacement therapy in Austria. Nephrol Dial Transplant. 2011 Sep;26(9):2988-95. doi: 10.1093/ndt/gfq780. Epub 2011 Feb 10.'}, {'pmid': '19207859', 'type': 'BACKGROUND', 'citation': 'Howard K, Salkeld G, White S, McDonald S, Chadban S, Craig JC, Cass A. The cost-effectiveness of increasing kidney transplantation and home-based dialysis. Nephrology (Carlton). 2009 Feb;14(1):123-32. doi: 10.1111/j.1440-1797.2008.01073.x.'}, {'pmid': '14633146', 'type': 'BACKGROUND', 'citation': 'Korevaar JC, Feith GW, Dekker FW, van Manen JG, Boeschoten EW, Bossuyt PM, Krediet RT; NECOSAD Study Group. Effect of starting with hemodialysis compared with peritoneal dialysis in patients new on dialysis treatment: a randomized controlled trial. Kidney Int. 2003 Dec;64(6):2222-8. doi: 10.1046/j.1523-1755.2003.00321.x.'}, {'pmid': '17080109', 'type': 'BACKGROUND', 'citation': 'Vonesh EF, Snyder JJ, Foley RN, Collins AJ. Mortality studies comparing peritoneal dialysis and hemodialysis: what do they tell us? Kidney Int Suppl. 2006 Nov;(103):S3-11. doi: 10.1038/sj.ki.5001910.'}, {'pmid': '21511830', 'type': 'BACKGROUND', 'citation': 'Perl J, Wald R, McFarlane P, Bargman JM, Vonesh E, Na Y, Jassal SV, Moist L. Hemodialysis vascular access modifies the association between dialysis modality and survival. J Am Soc Nephrol. 2011 Jun;22(6):1113-21. doi: 10.1681/ASN.2010111155. Epub 2011 Apr 21.'}, {'pmid': '11773473', 'type': 'BACKGROUND', 'citation': 'Heaf JG, Lokkegaard H, Madsen M. Initial survival advantage of peritoneal dialysis relative to haemodialysis. Nephrol Dial Transplant. 2002 Jan;17(1):112-7. doi: 10.1093/ndt/17.1.112.'}, {'pmid': '14569095', 'type': 'BACKGROUND', 'citation': 'Termorshuizen F, Korevaar JC, Dekker FW, Van Manen JG, Boeschoten EW, Krediet RT; Netherlands Cooperative Study on the Adequacy of Dialysis Study Group. Hemodialysis and peritoneal dialysis: comparison of adjusted mortality rates according to the duration of dialysis: analysis of The Netherlands Cooperative Study on the Adequacy of Dialysis 2. J Am Soc Nephrol. 2003 Nov;14(11):2851-60. doi: 10.1097/01.asn.0000091585.45723.9e.'}, {'pmid': '26897038', 'type': 'BACKGROUND', 'citation': 'Dias DB, Banin V, Mendes ML, Barretti P, Ponce D. Peritoneal dialysis can be an option for unplanned chronic dialysis: initial results from a developing country. Int Urol Nephrol. 2016 Jun;48(6):901-6. doi: 10.1007/s11255-016-1243-x. Epub 2016 Feb 20.'}, {'pmid': '23944971', 'type': 'BACKGROUND', 'citation': 'Silva TN, de Marchi D, Mendes ML, Barretti P, Ponce D. Approach to prophylactic measures for central venous catheter-related infections in hemodialysis: a critical review. Hemodial Int. 2014 Jan;18(1):15-23. doi: 10.1111/hdi.12071. Epub 2013 Aug 14.'}, {'pmid': '24117542', 'type': 'BACKGROUND', 'citation': 'Mendes ML, Castro JH, Silva TN, Barretti P, Ponce D. Effective use of alteplase for occluded tunneled venous catheter in hemodialysis patients. Artif Organs. 2014 May;38(5):399-403. doi: 10.1111/aor.12186. Epub 2013 Oct 3.'}, {'pmid': '21622993', 'type': 'BACKGROUND', 'citation': 'Koch M, Kohnle M, Trapp R, Haastert B, Rump LC, Aker S. Comparable outcome of acute unplanned peritoneal dialysis and haemodialysis. Nephrol Dial Transplant. 2012 Jan;27(1):375-80. doi: 10.1093/ndt/gfr262. Epub 2011 May 28.'}, {'pmid': '18424817', 'type': 'BACKGROUND', 'citation': 'Lobbedez T, Lecouf A, Ficheux M, Henri P, Hurault de Ligny B, Ryckelynck JP. Is rapid initiation of peritoneal dialysis feasible in unplanned dialysis patients? A single-centre experience. Nephrol Dial Transplant. 2008 Oct;23(10):3290-4. doi: 10.1093/ndt/gfn213. Epub 2008 Apr 19.'}, {'pmid': '26374834', 'type': 'BACKGROUND', 'citation': 'Alkatheeri AM, Blake PG, Gray D, Jain AK. Success of Urgent-Start Peritoneal Dialysis in a Large Canadian Renal Program. Perit Dial Int. 2016 Mar-Apr;36(2):171-6. doi: 10.3747/pdi.2014.00148. Epub 2015 Sep 15.'}, {'pmid': '19494623', 'type': 'BACKGROUND', 'citation': 'Povlsen JV. Unplanned start on assisted peritoneal dialysis. Contrib Nephrol. 2009;163:261-263. doi: 10.1159/000223808. Epub 2009 Jun 3.'}, {'pmid': '27461186', 'type': 'BACKGROUND', 'citation': 'Chang YT, Hwang JS, Hung SY, Tsai MS, Wu JL, Sung JM, Wang JD. Cost-effectiveness of hemodialysis and peritoneal dialysis: A national cohort study with 14 years follow-up and matched for comorbidities and propensity score. Sci Rep. 2016 Jul 27;6:30266. doi: 10.1038/srep30266.'}, {'pmid': '26354569', 'type': 'BACKGROUND', 'citation': 'Atapour A, Eshaghian A, Taheri D, Dolatkhah S. Hemodialysis versus peritoneal dialysis, which is cost-effective? Saudi J Kidney Dis Transpl. 2015 Sep;26(5):962-5. doi: 10.4103/1319-2442.164578.'}, {'pmid': '25526471', 'type': 'BACKGROUND', 'citation': 'Liu FX, Ghaffari A, Dhatt H, Kumar V, Balsera C, Wallace E, Khairullah Q, Lesher B, Gao X, Henderson H, LaFleur P, Delgado EM, Alvarez MM, Hartley J, McClernon M, Walton S, Guest S. Economic evaluation of urgent-start peritoneal dialysis versus urgent-start hemodialysis in the United States. Medicine (Baltimore). 2014 Dec;93(28):e293. doi: 10.1097/MD.0000000000000293.'}, {'pmid': '17886595', 'type': 'BACKGROUND', 'citation': 'Passadakis PS, Oreopoulos DG. Peritoneal dialysis in patients with acute renal failure. Adv Perit Dial. 2007;23:7-16.'}, {'pmid': '12773260', 'type': 'BACKGROUND', 'citation': 'Mowatt G, Vale L, Perez J, Wyness L, Fraser C, MacLeod A, Daly C, Stearns SC. Systematic review of the effectiveness and cost-effectiveness, and economic evaluation, of home versus hospital or satellite unit haemodialysis for people with end-stage renal failure. Health Technol Assess. 2003;7(2):1-174. doi: 10.3310/hta7020. No abstract available.'}, {'pmid': '11446130', 'type': 'BACKGROUND', 'citation': 'Kirby L, Vale L. Dialysis for end-stage renal disease. Determining a cost-effective approach. Int J Technol Assess Health Care. 2001 Spring;17(2):181-9. doi: 10.1017/s0266462300105045.'}, {'pmid': '33501650', 'type': 'DERIVED', 'citation': 'Htay H, Johnson DW, Craig JC, Teixeira-Pinto A, Hawley CM, Cho Y. Urgent-start peritoneal dialysis versus haemodialysis for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jan 27;1(1):CD012899. doi: 10.1002/14651858.CD012899.pub2.'}, {'pmid': '33320346', 'type': 'DERIVED', 'citation': 'Htay H, Johnson DW, Craig JC, Teixeira-Pinto A, Hawley CM, Cho Y. Urgent-start peritoneal dialysis versus conventional-start peritoneal dialysis for people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 15;12(12):CD012913. doi: 10.1002/14651858.CD012913.pub2.'}], 'seeAlsoLinks': [{'url': 'http://kidney.org/kidneydisease/global-facts-about-kidney-disease', 'label': 'National Kidney Foundation. 2016'}, {'url': 'http://www.nephrology.dk', 'label': 'Danish Nephrology Registry, Annual Report 2011'}, {'url': 'http://www.sbn.org.br', 'label': 'Census of the Brazillian Society of Nephrology 2014'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the cost-effectiveness of unplanned dialysis (peritoneal dialysis and hemodialysis) in chronic kidney disease (CKD) during the first year of therapy in a single center.', 'detailedDescription': 'Despite evidence of worse outcomes, initiation of renal replacement therapy by unplanned modalities in chronic kidney disease (CKD) patients is the reality in the practice for both hemodialysis and peritoneal dialysis. Unplanned therapy peritoneal dialysis (PD) is the initiation of the modality in less than 48 hours after implantation of the peritoneal catheter, without family training or adequacy of the home. Unplanned hemodialysis (HD) is the initiation of the method without a functional arteriovenous fistula, i.e., with a central venous catheter (nontunneled or tunneled).\n\nGrowing evidence shows unplanned PD (or urgent start PD) as a viable and safe alternative to unplanned HD, with the similar rates of infection and survival.\n\nOn planned scenario, solid studies demonstrate that PD has a better cost-effectiveness when compared to HD, however the literature lacks in this kind of analysis in unplanned methods.\n\nBriefly, the workgroup will follow patients that would anyway start a Renal Replacement Therapy by an unplanned method and register Government payment for the therapy, including the therapy direct costs and the costs with events (internation, infection), access for dialysis, laboratory and CKD specific medications to performed a cost-effectiveness analysis in both groups (Unplanned Hemodialysis and Unplanned Peritoneal Dialysis).\n\nThe workgroup is responsible for the placement of the catheters (PD and HD) using the Seldinger Technique.\n\nThe study is unicentric, the therapy is continuous and necessary for the maintenance of life; therefore, no great difficult in the follow up is expected. A database with up-to-date information of patients will be functional during the study.\n\nA Markov model will be developed to assess the relative cost-effectiveness of different dialysis modality distribution scenarios versus current practice. The model considers a hypothetical adult incident patient cohort with end-stage renal disease (ESRD) requiring dialysis and adopts payer perspective. Markov models have been used to model dialysis treatment in previous economic analyses and are widely accepted to be suitable for modelling chronic condition\n\nStatistical analysis plan:\n\nFrom the study protocol, the data will be entered in a spreadsheet and verified typographical errors and their analysis will be performed using the statistical program Statistical Analysis System (SAS) for Windows (version 9.2: SAS Institute, Cary, North Carolina, USA, 2012).\n\nConsidering an alpha error of 0.05 and a beta error of 0.2, power of statistic test of 0.8 and cost difference detection between groups of 15%, the calculated sample size for each group is 94 patients.\n\nInitially descriptive analysis will be done for all patients treated in the period, calculated measures of central tendency and dispersion for continuous variables and frequencies for categorical variables.\n\nFor the analysis of repeated measures, asymmetric distribution (gamma) under the Generalized Linear Model (GENMOD) procedure will be used.\n\nChi Square will be used to compare categorical variable between the two groups. T test or Mann-Whitney will be used to compare parametric continue variables.\n\nBy the utilization of Kaplan Meyer and log rank, survival curves of the two groups will be presented at the end of the study. A p-value of 5% or lower will be considered to be statistically significant'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Incident dialysis patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ambulatorial Chronic Kidney Disease patients stage 5 (eGFR \\< 15 ml/min) or stages 4 with abrupt worsening requiring dialysis treatment immediately followed or not by nephrologists prior to Renal Replacement Therapy indication.\n\nExclusion Criteria:\n\n* Transitions between HD and PD\n* Patients with functional arteriovenous fistula entering hemodialysis\n* Patients with functional PD access implanted ate least 48h before the first use\n* Patient or family trained in PD and/or with the right adequacy of the home'}, 'identificationModule': {'nctId': 'NCT03474367', 'briefTitle': 'Cost-effectiveness of Urgent-start Therapies Hemodialysis and Peritoneal Dialysis', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Estadual Paulista Júlio de Mesquita Filho'}, 'officialTitle': 'Cost-effectiveness of Urgent-start Therapies Hemodialysis and Peritoneal Dialysis', 'orgStudyIdInfo': {'id': '97/2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Unplanned Peritoneal Dialysis', 'description': 'CKD patients stage 5 (eGFR \\< 15 ml/min/1,73m²) or stages 4 with abrupt worsening renal function requiring dialysis treatment immediately, followed or not by nephrologists prior to renal replacement therapy (RRT) indication, that agree to initiate peritoneal dialysis (PD) in less than 48 hours after implantation of the peritoneal catheter, without family training or adequacy of the home. The patient must not have any absolute contraindications to initiate PD, which include: presence of recent abdominal surgery (less than 30 days); multiple previous abdominal surgery (more than two); presence of fibrosis or peritoneal adhesions; fungal peritonitis; severe respiratory insufficiency (FiO2\\> 70%); abdominal infections; severe hyperkalemia with changes characteristic in ECG; and acute pulmonary edema. These patients will be treated with HD.'}, {'label': 'Unplanned Hemodialysis', 'description': 'CKD patients stage 5 (eGFR \\< 15 ml/min/1,73m²) or stages 4 with abrupt worsening renal function requiring dialysis treatment immediately, followed or not by nephrologists prior to renal replacement therapy (RRT) indication, that agree to initiate HD without a functional arteriovenous fistula, ie, with a central venous catheter (nontunneled or tunneled).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '18606-260', 'city': 'Botucatu', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clínicas da Faculdade de Medicina de Botucatu', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Estadual Paulista Júlio de Mesquita Filho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mastering Student', 'investigatorFullName': 'Alexandre Minetto Brabo', 'investigatorAffiliation': 'Universidade Estadual Paulista Júlio de Mesquita Filho'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-10-09', 'type': 'RELEASE'}, {'date': '2021-10-10', 'type': 'UNRELEASE'}, {'date': '2025-01-08', 'type': 'RELEASE'}, {'date': '2025-01-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Alexandre Minetto Brabo, PhD student, Universidade Estadual Paulista Júlio de Mesquita Filho'}}}}