Short Daily Hemodialysis and Online HDF: Which One is Bet... | NCT00939445

Studies
Short Daily Hemodialysis and Online HDF: Which One is Better?

NCT00939445

Sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Status

Completed

Last Update Posted

Dec 15, 2015Estimated

Enrollment

10Actual

Phase

Phase 3

Conditions

End Stage Renal Disease

Interventions

Online HDF
Short Daily Hemodialysis

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Jul 14, 2009

First Submission Date that Met QC Criteria

Jul 14, 2009

First Posted Date

Jul 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2015

Last Update Posted Date

Dec 15, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thananda Trakarnvanich, Associate Professor, Bangkok Metropolitan Administration Medical College and Vajira HospitalPrincipal Investigator

Lead Sponsor

Bangkok Metropolitan Administration Medical College and Vajira HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

1. To compare the efficacy of

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Online HDF	Active Comparator	Online HDF	Procedure: Online HDF
Short Daily Hemodialysis	Active Comparator	Short Daily Hemodialysis	Procedure: Short Daily Hemodialysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Online HDF	Procedure	Online HDF	Online HDF
Short Daily Hemodialysis

Measure	Description	Time Frame
Adequacy		3 months

Measure	Description	Time Frame
Hematocrit, calcium, phosphorus		3 months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renal Unit, BMA Medical College and Vajira Hospital		Bangkok		10300	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided