Chronic Renal DiseaseNCT02072837
Dyslipidemia-related Risk Factors in Dialysis
An observational study of Chronic Renal Disease and Cardiovascular Disease, run by National and Kapodistrian University of Athens.
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… Read more about this study
- Who is it for?
- Ages 24 to 87 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Disease, Cardiovascular Disease, Dyslipidemia
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 87 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- permanent renal replacement therapy more than 6 months and
- accurate dry body weight
Who cannot join
- acute illness,
- significant infection,
- malignancy,
- Kt/V for urea <1.2.
About this study
Official title: Dyslipidemia-related Variables as Risk Factor for Cardiovascular Disease in Patients on the End-stage of Renal Disease
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.
Read the 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.
- Conditions
- Chronic Renal Disease, Cardiovascular Disease, Dyslipidemia
- Keywords
- hemodialysis, dyslipidemia, cardiovascular disease
- Medical subject headings
- Renal Insufficiency, Chronic, Cardiovascular Diseases, Dyslipidemias
What is being measured
The primary outcome is the main question the study is designed to answer.
Associations between dyslipidemia with cardiovascular disease on patients on renal replacement therapy
Measured: February 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal DiseaseStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vaia D.Raikou, National and Kapodistrian University of Athens
- Investigators
- Vaia D. Raikou, Ph.D, Principal investigator, National & Kapodistrian University of Athens, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072837
- Sponsor's protocol ID
- E.S.931/5-12-2006
- Status last verified
- Feb 2014
- First submitted
- 25 Feb 2014
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyslipidemia-related Variables as Risk Factor for Cardiovascular Disease in Patients on the End-stage of Renal Disease
- ClinicalTrials.gov ID
- NCT02072837
- Acronym / sponsor ID
- E.S.931/5-12-2006
- Conditions
- Chronic Renal Disease, Cardiovascular Disease, Dyslipidemia
- Keywords
- hemodialysis, dyslipidemia, cardiovascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 24 to 87 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- permanent renal replacement therapy more than 6 months and
- accurate dry body weight
Key exclusion criteria (4 listed)
- acute illness,
- significant infection,
- malignancy,
- Kt/V for urea <1.2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Associations between dyslipidemia with cardiovascular disease on patients on renal replacement therapy
Time frame: February 2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vaia D. Raikou, Ph.D principal investigator
National & Kapodistrian University of Athens, School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Renal Disease and Cardiovascular Disease, run by National and Kapodistrian University of Athens.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Associations between dyslipidemia with cardiovascular disease on patients on renal replacement therapy (time frame: February 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014.