Cardiovascular DiseasesNCT00182338
Evaluation of Volume Status in Peritoneal Dialysis Patients
An observational study of Cardiovascular Diseases and Inflammation, run by McMaster University at 1 site in Canada.
Trial summary
Patients with kidney failure on dialysis have a much higher risk of developing cardiovascular disease as compared to the general population. Recently, two large studies have shown that increasing the amount of dialysis does not decrease cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Inflammation, Peritoneal Dialysis
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2005to Jan 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Peritoneal dialysis clinic
Who may be able to join
- Adult patients,
- 18 years of age or older,
- with end stage renal disease on peritoneal dialysis for a minimum of 3 months
Who cannot join
- Peritonitis in previous 3 months;
- history of bilateral lower limb amputation;
- inability to provide informed consent;
- presence of a pacemaker or defibrillator;
- anticipated death or transplant within 6 months of recruitment
Trial locations and contacts
1 site in 1 country.
About this study
Patients with kidney failure on dialysis have a much higher risk of developing cardiovascular disease as compared to the general population. Recently, two large studies have shown that increasing the amount of dialysis does not decrease cardiovascular disease. It is known that retaining too much fluid leads to high blood pressure and thickening of the heart wall. Peritoneal dialysis is a method of home dialysis which allows dialysis patients autonomy and independence. This study will measure blood levels of a protein called N-BNP and measure the extent of body fluid by a machine called a bioimpedance analyzer. This device administers an undetectible electric current which distributes throughout total body water. The relationship between these tests and the clinical presence of volume expansion will be assessed. In addition, the extent of total body fluid and it's impact on heart attacks, heart failure and stroke will be determined.
Read the detailed description
Patients with end-stage renal disease (ESRD) have a higher risk than the general population of developing premature cardiovascular disease; the reasons for this are complex. Two recent randomized controlled trials in peritoneal dialysis patients have demonstrated that targeting patients to higher dialysis clearance values is not associated with a reduction in mortality. It is known that patients on peritoneal dialysis are more likely to be volume expanded, develop left ventricular hypertrophy, and have inadequate blood pressure relative to patients on hemodialysis. As a result there has been increased attention on the role of fluid management in reducing the risk of developing congestive heart failure and other adverse cardiovascular events in peritoneal dialysis patients.
Extracellular fluid volume and total body water can be accurately assessed with multi-frequency bioimpedance analysis (BIA). Estimation of volume expansion by measuring the natriuretic peptide N-BNP produced by cardiac tissue in response to ventricular wall stretch can also be used.
The purpose of this study is to determine whether volume status, as measured by BIA and N-BNP levels, correlates with clinical volume assessment, cardiovascular outcomes, peritoneal membrane transport properties and markers of inflammation such as serum albumin and C-reactive protein.
- Conditions
- Cardiovascular Diseases, Inflammation, Peritoneal Dialysis
- Keywords
- cardiovascular outcomes, congestive heart failure, Peritoneal Membrane transport properties, Arterial stiffening, Inflammatory markers
- Medical subject headings
- Cardiovascular Diseases, Inflammation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal Dialysis Patients | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Investigators
- Scott K Brimble, MD, Principal investigator, McMaster UniversityPeter Margetts, MD, PhD, Study director, McMaster UniversityDavid N Churchill, MD, MSc, Study director, McMaster UniversityAzim S Gangji, MD, Study director, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182338
- Sponsor's protocol ID
- PD 04-2305
- Status last verified
- Jul 2011
- First submitted
- 13 Sep 2005
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Gangji AS, Brimble KS, Margetts PJ. Association between markers of inflammation, fibrosis and hypervolemia in peritoneal dialysis patients. Blood Purif. 2009;28(4):354-8. doi: 10.1159/000232937. Epub 2009 Sep 1.
PubMed 19729905Gangji AS, Helal BA, Churchill DN, Brimble KS, Margetts PJ. Association between N-terminal propeptide B-type natriuretic peptide and markers of hypervolemia. Perit Dial Int. 2008 May-Jun;28(3):308-11. No abstract available.
PubMed 18474925
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Volume Status in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT00182338
- Acronym / sponsor ID
- PD 04-2305
- Conditions
- Cardiovascular Diseases, Inflammation, Peritoneal Dialysis
- Keywords
- cardiovascular outcomes, congestive heart failure, Peritoneal Membrane transport properties, Arterial stiffening, Inflammatory markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- Jan 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 16 Sep 2005 (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.
Patients with kidney failure on dialysis have a much higher risk of developing cardiovascular disease as compared to the general population. Recently, two large studies have shown that increasing the amount of dialysis does not decrease cardiovascular disease. It is known that retaining too much fluid leads to high blood pressure and thickening of the heart wall. Peritoneal dialysis is a method of home dialysis which allows dialysis patients autonomy and independence. This study will measure blood levels of a protein called N-BNP and measure the extent of body fluid by a machine called a bioimpedance analyzer. This device administers an undetectible electric current which distributes throughout total body water. The relationship between these tests and the clinical presence of volume expansion will be assessed. In addition, the extent of total body fluid and it's impact on heart attacks, heart failure and stroke will be determined.
Detailed description
Patients with end-stage renal disease (ESRD) have a higher risk than the general population of developing premature cardiovascular disease; the reasons for this are complex. Two recent randomized controlled trials in peritoneal dialysis patients have demonstrated that targeting patients to higher dialysis clearance values is not associated with a reduction in mortality. It is known that patients on peritoneal dialysis are more likely to be volume expanded, develop left ventricular hypertrophy, and have inadequate blood pressure relative to patients on hemodialysis. As a result there has been increased attention on the role of fluid management in reducing the risk of developing congestive heart failure and other adverse cardiovascular events in peritoneal dialysis patients.
Extracellular fluid volume and total body water can be accurately assessed with multi-frequency bioimpedance analysis (BIA). Estimation of volume expansion by measuring the natriuretic peptide N-BNP produced by cardiac tissue in response to ventricular wall stretch can also be used.
The purpose of this study is to determine whether volume status, as measured by BIA and N-BNP levels, correlates with clinical volume assessment, cardiovascular outcomes, peritoneal membrane transport properties and markers of inflammation such as serum albumin and C-reactive protein.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peritoneal Dialysis Patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Peritoneal dialysis clinic
Key inclusion criteria (3 listed)
- Adult patients,
- 18 years of age or older,
- with end stage renal disease on peritoneal dialysis for a minimum of 3 months
Key exclusion criteria (5 listed)
- Peritonitis in previous 3 months;
- history of bilateral lower limb amputation;
- inability to provide informed consent;
- presence of a pacemaker or defibrillator;
- anticipated death or transplant within 6 months of recruitment
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
Not reported in the source record.
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 20 Jul 2011.
- Results publication: PubMed 19729905Gangji AS, Brimble KS, Margetts PJ. Association between markers of inflammation, fibrosis and hypervolemia in peritoneal dialysis patients. Blood Purif. 2009;28(4):354-8. doi: 10.1159/000232937. Epub 2009 Sep 1.
- Results publication: PubMed 18474925Gangji AS, Helal BA, Churchill DN, Brimble KS, Margetts PJ. Association between N-terminal propeptide B-type natriuretic peptide and markers of hypervolemia. Perit Dial Int. 2008 May-Jun;28(3):308-11. No abstract available.
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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.
Scott K Brimble, MD principal investigator
McMaster University
Peter Margetts, MD, PhD study director
McMaster University
David N Churchill, MD, MSc study director
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Inflammation, run by McMaster University at 1 site in Canada.
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 3 inclusion and 5 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 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182338, which also lists 2 linked publications.
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 20 Jul 2011.