Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments

Dallas VA Medical Center

Status: Unknown

Conditions: Cardiovascular Disease

Treatments: Procedure: dialysis

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00925483

#04-050

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups

daily long

Experimental group

Description:

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

Treatment:

Procedure: dialysis

daily short

Experimental group

Description:

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

Treatment:

Procedure: dialysis

alternate day conventional

Experimental group

Description:

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

Treatment:

Procedure: dialysis

alternate day long

Experimental group

Description:

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

Treatment:

Procedure: dialysis