Short Daily Hemodialysis and Online HDF: Which One is Better? (SHD)

December 13, 2015 updated by: Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital

1. To compare the efficacy of

  1. Short Daily Hemodialysis
  2. Online HDF in term of adequacy of dialysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators intend to compare the efficacy between these modalities of treatment in terms of adequacy and also other parameters such as calcium-phosphorus balance and hematocrit

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 3

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, Thailand, 10300
        • Renal Unit, BMA Medical College and Vajira 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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • stable ESRD
  • KT/V > 1.2 for thrice weekly or > 1.8 for twice weekly

Exclusion Criteria:

  • Inadequate vascular access flow rate
  • Concurrent medical illnesses
  • History of non-compliance

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Online HDF
Procedure: Online HDF
Online HDF
Active Comparator: Short Daily Hemodialysis
Procedure: Short Daily Hemodialysis
Short Daily Hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adequacy
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Hematocrit, calcium, phosphorus
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

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

June 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

July 14, 2009

First Submitted That Met QC Criteria

July 14, 2009

First Posted (Estimate)

July 15, 2009

Study Record Updates

Last Update Posted (Estimate)

December 15, 2015

Last Update Submitted That Met QC Criteria

December 13, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VJR-NEPHRO001

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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