Individualized Incremental Hemodialysis Study

NCT03352271 | Completed

• 1 other identifier: MER17MD
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hemodialysis Complication; ESRD; Renal Failure

Keywords

Incremental hemodialysis; Precision medicine; Individualized care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• All-cause hospitalization rate

  24 months

• Preservation of residual kidney function

  24 months

• Development of hypertrophic cardiomyopathy

  24 months

• Cost of care

  24 months

• Estimation of quality of life (QOL)

  24 months

Study Arms (2)

Individualized Incremental hemodialysis

EXPERIMENTAL

ESRD patients starting an individualized (twice/week, once/week, once/10 days or less frequent) incremental hemodialysis program.

Procedure: Individualized Incremental hemodialysis

Thrice weekly dialysis

ACTIVE COMPARATOR

ESRD patients initiating a conventional thrice weekly hemodialysis program

Procedure: Conventional thrice weekly hemodialysis

Interventions

Individualized Incremental hemodialysis PROCEDURE

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.

Individualized Incremental hemodialysis

Conventional thrice weekly hemodialysis PROCEDURE

Thrice weekly hemodialysis program, the current standard of care for all patients, as a control

Thrice weekly dialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Children \< 18 years of age.
• Patients who were previously on other types of RRT, either on peritoneal dialysis, or on kidney transplant.
• Recent (within 3 months) acute kidney injury (AKI).
• Urine output less than 0.5 L/day.
• Active inflammatory disease with immunosuppressive treatment.
• Decompensated Liver disease, Hepatorenal syndrome.
• Cardiovascular disease defined as: heart failure type IV of the New York Heart Association (NYHA) or Cardiorenal syndrome.

Sponsors & Collaborators

• Alexandria University: lead
• Kidney and urology Center: collaborator
• Mansoura University: collaborator
• Fasila Hemodialysis Center: collaborator

Study Sites (2)

Mansoura University

Mansourah, Alexandria Governorate, 21529, Egypt

Location

kidney and Urology Center

Alexandria, Egypt

Location

Related Publications (17)

• 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. No abstract available.

  PMID: 28944775 BACKGROUND

• 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.

  PMID: 28090764 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.

  PMID: 26867814 BACKGROUND

• 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.

  PMID: 26656764 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.

  PMID: 26038351 BACKGROUND

• 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.

  PMID: 24840669 BACKGROUND

• 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. No abstract available.

  PMID: 25060001 BACKGROUND

• 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.

  PMID: 24016197 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.

  PMID: 25616635 BACKGROUND

• 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.

  PMID: 24322579 BACKGROUND

• 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.

  PMID: 21819316 BACKGROUND

• 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.

  PMID: 22612193 BACKGROUND

• Fernandez-Lucas M, Teruel-Briones JL, Gomis-Couto A, Villacorta-Perez J, Quereda-Rodriguez-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.

  PMID: 23169359 BACKGROUND

• 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. doi: 10.1159/000013533.

  PMID: 10592355 BACKGROUND

• 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.

  PMID: 22212562 BACKGROUND

• 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.

  PMID: 19019171 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.

  PMID: 27477358 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed E Elrggal, MD

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Mohamed A Sobh, MD

  Mansoura University

  STUDY CHAIR

• Hussein A Sheashaa, MD

  Mansoura University

  STUDY CHAIR

• Ahmed F Elkeraie, MD

  Alexandria University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Nephrologist

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 24, 2017
• Study Start: June 1, 2017
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Locations

EG (2)