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

July 26, 2016 updated by: Khajohn Tiranathanagul, Chulalongkorn University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Pathumwan, Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

End-stage renal disease patients who had been received long-term hemodiafiltration at King Chulalongkorn Memorial hospital during 2001-2013

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: 10 years
The Kaplan-Meier survival curve and mean survival time will be demonstrated for primary outcome.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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
10 years
Factors that associated with all-cause mortality
Time Frame: 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)
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

October 13, 2015

First Posted (ESTIMATE)

October 15, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 455/56

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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