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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital
ClinicalTrials.gov Identifier:
NCT00939445
First received: July 14, 2009
Last updated: December 13, 2015
Last verified: December 2015
  Purpose

1. To compare the efficacy of

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

Condition Intervention Phase
End Stage Renal Disease
Procedure: Online HDF
Procedure: Short Daily Hemodialysis
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short Daily Hemodialysis and Online HDF: Which One is Better?

Resource links provided by NLM:


Further study details as provided by Bangkok Metropolitan Administration Medical College and Vajira Hospital:

Primary Outcome Measures:
  • Adequacy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hematocrit, calcium, phosphorus [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: June 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Online HDF
Online HDF
Procedure: Online HDF
Online HDF
Active Comparator: Short Daily Hemodialysis
Short Daily Hemodialysis
Procedure: Short Daily Hemodialysis
Short Daily Hemodialysis

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939445

Locations
Thailand
Renal Unit, BMA Medical College and Vajira Hospital
Bangkok, Thailand, 10300
Sponsors and Collaborators
Bangkok Metropolitan Administration Medical College and Vajira Hospital
  More Information

Responsible Party: Thananda Trakarnvanich, Associate Professor, Bangkok Metropolitan Administration Medical College and Vajira Hospital
ClinicalTrials.gov Identifier: NCT00939445     History of Changes
Other Study ID Numbers: VJR-NEPHRO001 
Study First Received: July 14, 2009
Last Updated: December 13, 2015
Health Authority: Thailand: Bangkok Metropolitan Administration

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on May 25, 2016