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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Bangkok Metropolitan Administration Medical College and Vajira Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bangkok Metropolitan Administration Medical College and Vajira Hospital
ClinicalTrials.gov Identifier:
NCT00939445
First received: July 14, 2009
Last updated: July 14, 2011
Last verified: July 2009
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 10
Study Start Date: June 2009
Estimated Study Completion Date: September 2011
Estimated 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
Other Name: Online HDF
Active Comparator: Short Daily Hemodialysis
Short Daily Hemodialysis
 Procedure: Short Daily Hemodialysis
Short Daily Hemodialysis
Other Name: 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939445

Contacts
Contact: Thananda Trakarnvanich, MD 662-244-3469 thananda@hotmail.com

Locations
Thailand
Renal Unit, BMA Medical College and Vajira Hospital Recruiting
Bangkok, Thailand, 10300
Contact: Thananda Trakarnvanich, MD     662-244-3469     thananda@hotmail.com    
Sponsors and Collaborators
Bangkok Metropolitan Administration Medical College and Vajira Hospital
  More Information

No publications provided

Responsible Party: Thananda Trakarnvanich, BMA Medical College
ClinicalTrials.gov Identifier: NCT00939445     History of Changes
Other Study ID Numbers: VJR-NEPHRO001
Study First Received: July 14, 2009
Last Updated: July 14, 2011
Health Authority: Thailand: Bangkok Metropolitan Administration

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

ClinicalTrials.gov processed this record on May 23, 2013