Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments

NCT ID: NCT00925483

Last Updated: 2010-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Brief Summary

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Given the known increased risk of heart disease in hemodialysis patients, this study aims to evaluate the change in both size and function of the heart by using cardiac magnetic resonance imaging (MRI) in patients undergoing either daily long (4 hours, 6 times weekly), daily short (2 hours 6 times weekly), or alternate day conventional (4 hours, 3 times weekly) and alternate day long (8 hours, 3 times weekly) dialysis for 6 months from randomization. The patients are randomly put in the groups based on predetermined randomization schedule and the cardiologist trained in cardiac MRI readings is blinded to the patient treatment schedule. Given that changes in heart function may be seen with cardiac imaging techniques within 6 months, the expectation is that groups on daily treatment may have better outcome for this parameter as changes in volume and blood pressure may also be affected in a positive way in patients on daily dialysis.

Detailed Description

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Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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daily long

daily long (4 hours, 6 times weekly) dialysis for 6 months

Group Type EXPERIMENTAL

dialysis

Intervention Type PROCEDURE

different dialysis schedules for each arm

daily short

daily short (2 hours 6 times weekly) dialysis for 6 months

Group Type EXPERIMENTAL

dialysis

Intervention Type PROCEDURE

different dialysis schedules for each arm

alternate day conventional

alternate day conventional (4 hours, 3 times weekly) dialysis for 6 months

Group Type EXPERIMENTAL

dialysis

Intervention Type PROCEDURE

different dialysis schedules for each arm

alternate day long

alternate day long (8 hours, 3 times weekly) dialysis for 6 months

Group Type EXPERIMENTAL

dialysis

Intervention Type PROCEDURE

different dialysis schedules for each arm

Interventions

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dialysis

different dialysis schedules for each arm

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* End stage renal disease patients on hemodialysis

Exclusion Criteria

* Weight \> 350 lbs
* Known poor dialysis and or treatment compliance
* Unable to come for daily treatments if randomization occurs in this group
* Prognosis less than 6 months
* Difficulty in tolerating dialysis and possibility of discontinuation of dialysis before 6 months
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dallas VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Dallas VA Medical Center

Principal Investigators

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Devasmita C. Dev, MD

Role: PRINCIPAL_INVESTIGATOR

VA North Texas Health Care System, Dallas VA Medical Center

Locations

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Dallas VA Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Devasmita C. Dev, MD

Role: CONTACT

214-857-1593

Facility Contacts

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Devasmita C. Dev, MD

Role: primary

214-857-1593

Other Identifiers

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#04-050

Identifier Type: -

Identifier Source: org_study_id

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