Dyslipidemia-related Risk Factors in Dialysis

Cardiovascular Disease Clinical Trial

Official title:

Dyslipidemia-related Variables as Risk Factor for Cardiovascular Disease in Patients on the End-stage of Renal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072837
• Other study ID #: E.S.931/5-12-2006
• Status: Completed
• Phase: N/A
• First received: February 25, 2014
• Last updated: February 27, 2014
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial Summary

In this study, we studied lipoprotein abnormalities-related variables as risk factors for the development of cardiovascular disease in patients on renal replacement therapies.We studied 96 dialyzed patients, 62 males and 34 females, on mean age 62.1 years old and 24 healthy controls.We concluded that metabolic acidosis activating the inflammation and lipoprotein oxidation influences the dyslipidemia and cardiovascular morbidity of patients on renal replacement therapies.Dialysis adequacy was positively associated to cardioprotective HDL.Peritoneal dialysis holds a better acidosis level and lower oxidized lipids than hemodialysis modalities.

Description:

Blood samples were obtained by venipuncture in the peritoneal dialyzed patients and control group in a twelve hours fasting state.In hemodialyzed patients blood was drawn just before the start of the mean weekly dialysis session also in a twelve hours fasting state from the vascular access.

All samples were received once at baseline time ( in the start of the study ). Peripheral systolic and diastolic blood pressures were calculated as an average of 10 measurements during a renal replacement treatment month in the starting time of the study.

Also, electrocardiographic examination, echocardiography and the calculation of ankle-brachial blood pressure index became once in the start of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 24 Years to 87 Years

Eligibility

Inclusion Criteria:

• permanent renal replacement therapy more than 6 months and

• accurate dry body weight

Exclusion Criteria:

• acute illness,

• significant infection,

• malignancy,

• Kt/V for urea <1.2.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Renal Disease
• Dyslipidemia
• Dyslipidemias
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Associations between dyslipidemia with cardiovascular disease on patients on renal replacement therapy		February 2014	No