Comparison of Four and Eight Hours Dialysis Sessions in T... | NCT00413803

Studies
Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis

NCT00413803

Sponsor

Ege University

Status

Completed

Last Update Posted

Aug 4, 2009Estimated

Enrollment

410Actual

Phase

Phase 4

Conditions

End-Stage Renal Disease
Hemodialysis

Interventions

4-hour thrice weekly in center hemodialysis
8-hour thrice weekly in center hemodialysis

Countries

Turkey (Türkiye)

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

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

Dec 2006

Primary Completion Date

Feb 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

Dec 19, 2006

First Submission Date that Met QC Criteria

Dec 19, 2006

First Posted Date

Dec 20, 2006Estimated

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

Aug 3, 2009

Last Update Posted Date

Aug 4, 2009Estimated

Name	Class
Fresenius Medical Care North America	INDUSTRY

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

The investigators hypothesize that an increase in the duration of dialysis session in thrice weekly center hemodialysis may provide better outcome, less morbidity, higher quality of life, lesser requirement of medications, and lower total cost.

Detailed Description

The proposed prospective and controlled clinical trial aims to compare 4-hour and 8-hour dialysis sessions in thrice weekly center HD regarding mortality, hospitalization rate, several clinical and laboratory parameters, and total cost. Four hundred and ten HD patients will be taken into the study. The study will last for 12 months. The patients will be placed in two groups:

Four-hour dialysis session, blood flow rate 300-400 ml/min
Eight-hours dialysis session, blood flow rate 200-250 ml/min

Sample size is estimated with following hypotheses: twelve months duration of follow-up; twelve months survival of the control group 85%; a bilateral alpha risk equal to 5%; an expectation that 12-months survival to be 95% by 8-hours dialysis; a 85% power to detect the decrease in annual mortality by 8-hours dialysis comparing to 4-hours dialysis; a 10% of dropout rate. The required sample is total 410 patients.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

410Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	Four-hour dialysis session, blood flow rate 300-400 ml/min	Procedure: 4-hour thrice weekly in center hemodialysis
2	Active Comparator	Eight-hours dialysis session, blood flow rate 200-250 ml/min	Procedure: 8-hour thrice weekly in center hemodialysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
4-hour thrice weekly in center hemodialysis	Procedure	conventional hemodialysis	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
total mortality		one year

Secondary Outcomes

Measure	Description	Time Frame
cardiovascular mortality		one year
changes in health-related quality of life, depression burden, cognitive function		one year
required medications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older than 18-years
On maintenance bicarbonate HD scheduled thrice weekly 12 hours/week; achieved mean single pool Kt/V above 1.2
Willingness to participate in the study with a written informed consent

Exclusion Criteria:

To be scheduled for living donor renal transplantation
To have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease
Pregnancy or lactating
Current requirement for HD more than three times per week due to medical comorbidity
GFR greater than 10 ml/min/1.73 m2 as measured by the average of urea and creatinine clearances obtained from a urine collection of at least 24 hours
Use of temporary catheter
Current use of investigational drugs or participation in an interventional clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial
Mental incompetence

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ercan Ok, MD	Ege University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
FMC Turkey Clinics		Adana		01100	Turkey (Türkiye)
Ege University School of Medicine Nephrology Department

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22172590	Derived	Demirci MS, Celik G, Ozkahya M, Tumuklu M, Toz H, Asci G, Duman S, Basci A, Kircelli F, Ozdogan O, Demirci C, Can L, Isik IO, Ok E; Long Dialysis Group. Effects of thrice weekly nocturnal hemodialysis on arterial stiffness. Atherosclerosis. 2012 Feb;220(2):477-85. doi: 10.1016/j.atherosclerosis.2011.11.015. Epub 2011 Nov 19.

Type	Date	Date Unknown
Release	Oct 4, 2015
Reset	Oct 30, 2015

ID	Term
D007676	Kidney Failure, Chronic
D002318	Cardiovascular Diseases
D017379	Hypertrophy, Left Ventricular

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