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

Sponsor
Chulalongkorn University (Other)
Overall Status
Completed
CT.gov ID
NCT02576873
Collaborator
(none)
66
1
24
2.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Hemodiafiltration

Detailed 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

Study Design

Study Type:
Observational
Actual Enrollment :
66 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Hemodiafiltration

End-stage renal disease patients who were treated with high-efficiency hemodiafiltration for more than 6 months

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

Outcome Measures

Primary Outcome Measures

  1. Survival rate [10 years]

    The Kaplan-Meier survival curve and mean survival time will be demonstrated for primary outcome.

Secondary Outcome Measures

  1. 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. [10 years]

    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

  2. Factors that associated with all-cause mortality [10 years]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 King Chulalongkorn Memorial Hospital Pathumwan Bangkok Thailand 10330

Sponsors and Collaborators

  • Chulalongkorn University

Investigators

  • Principal Investigator: Khajohn Tiranathanagul, MD, Chulalongkorn University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Khajohn Tiranathanagul, Assistant Professor, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT02576873
Other Study ID Numbers:
  • 455/56
First Posted:
Oct 15, 2015
Last Update Posted:
Jul 28, 2016
Last Verified:
Jul 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Khajohn Tiranathanagul, Assistant Professor, Chulalongkorn University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2016