Individualized Incremental Hemodialysis Study

Renal Failure Clinical Trial

— IIHD  

Official title:

Comparison of Clinical Outcomes Between Thrice-weekly and Individualized Incremental Hemodialysis in Incident Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03352271
• Other study ID #: MER17MD
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Thrice weekly hemodialysis has been the standard of care all-over the world for end-stage renal disease (ESRD) requiring renal replacement therapy (RRT). Despite being in the era of precision medicine and individualized healthcare, this program doesn't take into account patients with residual kidney function (RKF) who don't require a thrice weekly hemodialysis frequency. Incremental hemodialysis (defined as twice weekly hemodialysis initiation in incident hemodialysis patients with residual kidney function) has been raised as an alternative to the conventional thrice weekly dialysis. Retrospective trials has proved safety of a twice weekly initiation with comparative efficacy to the thrice weekly program. Despite that, there is paucity of prospective observational and rarity of randomized controlled trials comparing both regimens. In this study, the investigators tend to provide a more individualized incremental hemodialysis approach to incident hemodialysis patients with residual urine volume and RKF. The investigators will compare the results to ESRD patients initiating a thrice weekly hemodialysis program.

Description:

This project aims to study the feasibility, safety and efficacy of individualized incremental (twice weekly, once weekly, once/10days or less frequent) hemodialysis (IIHD) initiation versus conventional thrice weekly HD for incident end stage renal disease (ESRD) patients with residual urine volume (RUV > 0.5 L/day, as a reference to residual kidney functions) who chose hemodialysis as their method of renal replacement therapy (RRT).

Incremental HD has been an area of research interest in the past few years with many publications discussing its feasibility and safety for incident HD patients. Smooth transition to dialysis in incident ESRD patients through incremental twice (or even once) weekly dialysis initiation has shown benefits in preservation of residual kidney functions (RKF) in comparison to thrice weekly HD. It has also been proposed as a method of reducing healthcare cost while providing quality healthcare to the patients(1). However, most available data are retrospective analysis, few data are present to compare the results to thrice weekly HD in a randomized controlled or even in a prospective manner. Incremental HD has been also practiced in some parts of Egypt in the last 2-3 years. The investigators will compare outcomes of participants starting a less frequent dialysis program to conventional thrice weekly HD in a multi-center study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with stage 5 chronic kidney disease (CKD) with estimated glomerular filtration rate of less than 10 ml/min/1.73m2 (using CKD-EPI equation for eGFR).

2. Residual urine volume at least 0.5 L/day or more.

Exclusion Criteria:

1. Children < 18 years of age.

2. Patients who were previously on other types of RRT, either on peritoneal dialysis, or on kidney transplant.

3. Recent (within 3 months) acute kidney injury (AKI).

4. Urine output less than 0.5 L/day.

5. Active malignancy at time of inclusion.

6. Active inflammatory disease with immunosuppressive treatment.

7. Decompensated Liver disease, Hepatorenal syndrome.

8. Cardiovascular disease defined as: heart failure type IV of the New York Heart Association (NYHA) or Cardiorenal syndrome.

Related Conditions & MeSH terms

• ESRD
• Hemodialysis Complication
• Renal Failure
• Renal Insufficiency

Intervention

Procedure:
• Individualized Incremental hemodialysis
Individualized Incremental hemodialysis program (twice/week, once/week, once/10days or less frequent) will be provided to incident ESRD patients according to their symptom presentation, clinical examination, investigations and daily urine volume measurement.
• Conventional thrice weekly hemodialysis
Thrice weekly hemodialysis program, the current standard of care for all patients, as a control

Locations

Country	Name	City	State
Egypt	kidney and Urology Center	Alexandria
Egypt	Mansoura University	Mansourah	Alexandria

Sponsors (4)

Lead Sponsor	Collaborator
Alexandria University	Fasila Hemodialysis Center, Kidney and urology Center, Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (17)

Bieber B, Qian J, Anand S, Yan Y, Chen N, Wang M, Wang M, Zuo L, Hou FF, Pisoni RL, Robinson BM, Ramirez SP. Two-times weekly hemodialysis in China: frequency, associated patient and treatment characteristics and Quality of Life in the China Dialysis Outcomes and Practice Patterns study. Nephrol Dial Transplant. 2014 Sep;29(9):1770-7. doi: 10.1093/ndt/gft472. Epub 2013 Dec 8. — View Citation

Diao Z, Zhang D, Dai W, Ding J, Zhang A, Liu W. Preservation of residual renal function with limited water removal in hemodialysis patients. Ren Fail. 2011;33(9):875-7. doi: 10.3109/0886022X.2011.605535. Epub 2011 Aug 8. — View Citation

Elamin S, Abu-Aisha H. Reaching target hemoglobin level and having a functioning arteriovenous fistula significantly improve one year survival in twice weekly hemodialysis. Arab J Nephrol Transplant. 2012 May;5(2):81-6. — View Citation

Elrggal ME, Zyada R. Gradual initiation of dialysis as a means to reduce cost while providing quality health care. Nat Rev Nephrol. 2017 Nov;13(11):720. doi: 10.1038/nrneph.2017.135. Epub 2017 Sep 25. — View Citation

Fernández-Lucas M, Teruel-Briones JL, Gomis-Couto A, Villacorta-Pérez J, Quereda-Rodríguez-Navarro C. Maintaining residual renal function in patients on haemodialysis: 5-year experience using a progressively increasing dialysis regimen. Nefrologia. 2012;32(6):767-76. doi: 10.3265/Nefrologia.pre2012.Jul.11517. English, Spanish. — View Citation

Hanson JA, Hulbert-Shearon TE, Ojo AO, Port FK, Wolfe RA, Agodoa LY, Daugirdas JT. Prescription of twice-weekly hemodialysis in the USA. Am J Nephrol. 1999;19(6):625-33. — View Citation

Kalantar-Zadeh K, Unruh M, Zager PG, Kovesdy CP, Bargman JM, Chen J, Sankarasubbaiyan S, Shah G, Golper T, Sherman RA, Goldfarb DS. Twice-weekly and incremental hemodialysis treatment for initiation of kidney replacement therapy. Am J Kidney Dis. 2014 Aug;64(2):181-6. doi: 10.1053/j.ajkd.2014.04.019. Epub 2014 May 17. Review. — View Citation

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. — View Citation

Lin X, Yan Y, Ni Z, Gu L, Zhu M, Dai H, Zhang W, Qian J. Clinical outcome of twice-weekly hemodialysis patients in shanghai. Blood Purif. 2012;33(1-3):66-72. doi: 10.1159/000334634. Epub 2011 Dec 29. — View Citation

Lin YF, Huang JW, Wu MS, Chu TS, Lin SL, Chen YM, Tsai TJ, Wu KD. Comparison of residual renal function in patients undergoing twice-weekly versus three-times-weekly haemodialysis. Nephrology (Carlton). 2009 Feb;14(1):59-64. doi: 10.1111/j.1440-1797.2008.01016.x. Epub 2008 Nov 19. — View Citation

Obi Y, Eriguchi R, Ou SM, Rhee CM, Kalantar-Zadeh K. What Is Known and Unknown About Twice-Weekly Hemodialysis. Blood Purif. 2015;40(4):298-305. doi: 10.1159/000441577. Epub 2015 Nov 17. — View Citation

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. — View Citation

Rhee CM, Ghahremani-Ghajar M, Obi Y, Kalantar-Zadeh K. Incremental and infrequent hemodialysis: a new paradigm for both dialysis initiation and conservative management. Panminerva Med. 2017 Jun;59(2):188-196. doi: 10.23736/S0031-0808.17.03299-2. Epub 2017 Jan 13. Review. — View Citation

Rhee CM, Unruh M, Chen J, Kovesdy CP, Zager P, Kalantar-Zadeh K. Infrequent dialysis: a new paradigm for hemodialysis initiation. Semin Dial. 2013 Nov-Dec;26(6):720-7. doi: 10.1111/sdi.12133. Epub 2013 Sep 9. Review. — View Citation

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. — View Citation

Vanholder R, Van Biesen W, Lameire N. Is starting hemodialysis on a twice-weekly regimen a valid option? Am J Kidney Dis. 2014 Aug;64(2):165-7. doi: 10.1053/j.ajkd.2014.06.003. — View Citation

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. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate after 24 months	To assess and compare Survival rate after 24 months in incident HD patients with individualized incremental HD (IIHD) as an RRT starting regimen, compared to those patients who start RRT with the conventional thrice weekly method.	24 months
Secondary	All-cause hospitalization rate	Rate of hospital admissions and number of days hospitalized for any cause (including cardiovascular events, CVE) during the 24 months.	24 months
Secondary	Preservation of residual kidney function	Preservation of Residual kidney function (time to anuria defined as urine output UOP < 100 ml/day, rate of decline of RKF defined as the slope in decline of daily UOP measured monthly) during the 24 months of follow up.	24 months
Secondary	Development of hypertrophic cardiomyopathy	Using Echocardiography to detect the development of hypertrophic cardiomyopathy	24 months
Secondary	Cost of care	comparing number of hemodialysis sessions in both groups multiplied by the cost of each session.	24 months
Secondary	Estimation of quality of life (QOL)	Comparing Quality of life survey values from Kidney Disease Quality of Life short form, KDQOL-SF v1.3, Arabic version between each group members	24 months
Secondary	Anemia Profile	Mean hemoglobin levels.	24 months
Secondary	Bone-mineral metabolism profile	Mean levels of calcium, phosphorus, parathyroid hormone PTH	24 months
Secondary	Vascular access complications	rate of infection, thrombosis and hematoma formation	24 months