Cost-effectiveness of Urgent-start Therapies Hemodialysis and Peritoneal Dialysis

Chronic Kidney Disease Requiring Chronic Dialysis Clinical Trial

Official title:

Cost-effectiveness of Urgent-start Therapies Hemodialysis and Peritoneal Dialysis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03474367
• Other study ID #: 97/2017
• Status: Active, not recruiting
• Start date: April 1, 2017
• Est. completion date: December 12, 2021

Study information

• Verified date: September 2019
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Growing 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.

On 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.

Briefly, 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).

The workgroup is responsible for the placement of the catheters (PD and HD) using the Seldinger Technique.

The 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.

A 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

Statistical analysis plan:

From 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).

Considering 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.

Initially 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.

For the analysis of repeated measures, asymmetric distribution (gamma) under the Generalized Linear Model (GENMOD) procedure will be used.

Chi 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.

By 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 198
• Est. completion date: December 12, 2021
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Transitions between HD and PD

• Patients with functional arteriovenous fistula entering hemodialysis

• Patients with functional PD access implanted ate least 48h before the first use

• Patient or family trained in PD and/or with the right adequacy of the home

Related Conditions & MeSH terms

• Chronic Kidney Disease Requiring Chronic Dialysis
• Cost-effectiveness Analysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina de Botucatu	Botucatu	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Country where clinical trial is conducted

Brazil, 

References & Publications (23)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Heaf JG, Løkkegaard H, Madsen M. Initial survival advantage of peritoneal dialysis relative to haemodialysis. Nephrol Dial Transplant. 2002 Jan;17(1):112-7. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Passadakis PS, Oreopoulos DG. Peritoneal dialysis in patients with acute renal failure. Adv Perit Dial. 2007;23:7-16. Review. — View 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. — View Citation

Povlsen JV. Unplanned start on assisted peritoneal dialysis. Contrib Nephrol. 2009;163:261-263. doi: 10.1159/000223808. Epub 2009 Jun 3. — View 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. Review. — View 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. — View 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. Review. — View Citation

Woo KT, Choong HL, Wong KS, Tan HB, Chan CM. 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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost effectiveness analysis of unplanned PD and HD at the General Hospital of the School of Medicine of Botucatu (HC-FMB)	Cost effectiveness analysis of unplanned PD and HD with the data collected at our center	12 months
Secondary	Cost effectiveness analysis of unplanned PD and HD in national and international scenario	Transpose the cost-effectiveness analysis to a national and international scenario, using a Markov model	12 months

External Links

•   Census of the Brazillian Society of Nephrology 2014
•   Danish Nephrology Registry, Annual Report 2011
•   National Kidney Foundation. 2016
•   U.S. Renal Data System. USRDS 2015 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States Bethesda, MD: USRDS; 2015