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Dyslipidemia-related Risk Factors in Dialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02072837
First Posted: February 27, 2014
Last Update Posted: February 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vaia D.Raikou, National and Kapodistrian University of Athens
  Purpose
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.

Condition
Chronic Renal Disease Cardiovascular Disease Dyslipidemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Dyslipidemia-related Variables as Risk Factor for Cardiovascular Disease in Patients on the End-stage of Renal Disease

Further study details as provided by Vaia D.Raikou, National and Kapodistrian University of Athens:

Primary Outcome Measures:
  • Associations between dyslipidemia with cardiovascular disease on patients on renal replacement therapy [ Time Frame: February 2014 ]

Enrollment: 96
Study Start Date: January 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Years to 87 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We studied 96 dialyzed patients at Nephrology Department of "Laiko, University General Hospital of Athens" and Renal Unit of "Diagnostic and Therapeutic Center of Athens Hygeia SA". 62 males and 34 females participated in this study.The treatment modalities which were applied were : regular haemodialysis (HD, n=34), predilution haemodiafiltration (HDF, n=42) and peritoneal dialysis (PD, n=20).
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072837


Sponsors and Collaborators
National and Kapodistrian University of Athens
Investigators
Principal Investigator: Vaia D. Raikou, Ph.D National & Kapodistrian University of Athens, School of Medicine
  More Information

Responsible Party: Vaia D.Raikou, Ph.D Nephrologist; Researcher, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT02072837     History of Changes
Other Study ID Numbers: E.S.931/5-12-2006
First Submitted: February 25, 2014
First Posted: February 27, 2014
Last Update Posted: February 28, 2014
Last Verified: February 2014

Keywords provided by Vaia D.Raikou, National and Kapodistrian University of Athens:
hemodialysis, dyslipidemia, cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Dyslipidemias
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Renal Insufficiency