Long-term Outcome of End-stage Renal Disease Patients Treated With Hig-efficiency Hemodiafiltration

End-stage Renal Disease Clinical Trial

Official title:

Long-term Outcome of End-stage Renal Disease Patients Treated With High-efficiency Hemodiafiltration: a Historical Cohort of a Single-center in South East Asia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576873
• Other study ID #: 455/56
• Status: Completed
• Phase: N/A
• First received: October 13, 2015
• Last updated: July 26, 2016
• Start date: March 2014
• Est. completion date: March 2016

Study information

• Verified date: July 2016
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial Summary

A retrospective cohort study was conducted in 66 end-stage renal disease patients who underwent high-efficiency hemodiafiltration technique in King Chulalongkorn Memorial Hospital between 2001-2013 to determine the survival rate as well as other long-term outcome.

Description:

Growing evidences suggested the superiority of high-efficiency hemodiafiltration (HDF) which could provide both diffusion and convection in a single therapy compared with the conventional hemodialysis. However, the long-term, upto 10 years, outcome still limited. This retrospective cohort study was conducted in 66 end-stage renal disease patients who underwent high-efficiency hemodiafiltration technique in a single-center, King Chulalongkorn Memorial Hospital, between 2001-2013 to determine the survival rate as well as other long-term outcome

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years or more

• Be diagnosed end-stage renal disease for more than one year

• Have been regularly received long-term hemodiafiltration for more than 6 months.

Exclusion Criteria:

• Patients who received hemodiafiltration less than 6 months

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Other:
• Hemodiafiltration
Hemodiafiltration treatments were prescribed to the patients as their long-term renal replacement therapies

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Pathumwan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate	The Kaplan-Meier survival curve and mean survival time will be demonstrated for primary outcome.	10 years	No
Secondary	Comparison of survival differences between patients who start renal replacement therapy with HDF and who switched from hemodialysis as well as between diabetic and non-diabetic patient.	Survival differences between groups will be evaluated with the Kaplan-Meier method and compared using the log-rank test. The comparative groups include: Patient who start renal replacement therapy with HDF (incident cases) vs. who switched from hemodialysis (prevalence cases); Diabetic vs. Non-diabetic patients	10 years	No
Secondary	Factors that associated with all-cause mortality	univariate and multivariate analysis the factors that might affected the long-term outcomes. The factors include dialytic parameters (spKt/Vurea, TAC urea), nutritional parameters (nPNA, albumin), inflammatory parameter (hsCRP), and biochemical parameters (BUN, Cr, Ca, Phosphate, iPTH, beta2-microglobulin, Hb, Ferritin, Transferrin saturation, Cholesterol, Triglyceride, HDL, and LDL)	10 years	No