Renal DiseaseBPNCT01330004
Blood Pressure Change and Outcome
An observational study of Renal Disease and High Blood Pressure, run by Renal Research Institute at 1 site in United States.
Trial summary
Hyper- and hypotension are important predictors of survival in non-ESRD (end stage renal disease) population. In dialysis patients, however, it has been shown that higher blood pressure levels may actually be beneficial to patient outcomes. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Renal Disease, High Blood Pressure
- How many people
- 12,695 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1999to Dec 2010
- 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 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Renal Research Institute hemodialysis patients
Who may be able to join
- Hemodialysis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship of Systolic and Diastolic Blood Pressure Changes Over Time to Patient Outcomes in Incident Hemodialysis Patients
Hyper- and hypotension are important predictors of survival in non-ESRD (end stage renal disease) population. In dialysis patients, however, it has been shown that higher blood pressure levels may actually be beneficial to patient outcomes. Dynamics of blood pressure evolution over time has not been previously studied in dialysis population. The investigators aim to understand how both blood pressure levels and blood pressure changes over time predict patient survival.
- Conditions
- Renal Disease, High Blood Pressure
- Medical subject headings
- Kidney Diseases, Hypertension
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 |
|---|---|---|
| Hemodialysis patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect size of the relation of dynamic changes of blood pressure (BP) at different ranges of BP to survival in incident hemodialysis patients.
The ranges of blood pressure measurements in mmHg over time and the relation to patient outcomes (including survival)
Measured: Up to 11 years and 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startJan 1999
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal DiseaseStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 12,695 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renal Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathan W Levin, MD, Principal investigator, Renal Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330004
- Sponsor's protocol ID
- 080-11
- Acronym
- BP
- Status last verified
- May 2015
- First submitted
- 31 Mar 2011
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Raimann JG, Usvyat LA, Thijssen S, Kotanko P, Rogus J, Lacson E Jr, Levin NW. Blood pressure stability in hemodialysis patients confers a survival advantage: results from a large retrospective cohort study. Kidney Int. 2012 Mar;81(6):548-58. doi: 10.1038/ki.2011.426. Epub 2012 Jan 4.
PubMed 22217879
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Systolic and Diastolic Blood Pressure Changes Over Time to Patient Outcomes in Incident Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01330004
- Acronym / sponsor ID
- BP / 080-11
- Conditions
- Renal Disease, High Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,695 participants (actual)
- Lead sponsor
- Renal Research InstituteUniversity, hospital or other
- Study start
- Jan 1999
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Apr 2011 (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.
Hyper- and hypotension are important predictors of survival in non-ESRD (end stage renal disease) population. In dialysis patients, however, it has been shown that higher blood pressure levels may actually be beneficial to patient outcomes. Dynamics of blood pressure evolution over time has not been previously studied in dialysis population. The investigators aim to understand how both blood pressure levels and blood pressure changes over time predict patient survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patients | – | – |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Renal Research Institute hemodialysis patients
Key inclusion criteria (1 listed)
- Hemodialysis
Key exclusion criteria (0 listed)
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
Effect size of the relation of dynamic changes of blood pressure (BP) at different ranges of BP to survival in incident hemodialysis patients.
Time frame: Up to 11 years and 11 months
The ranges of blood pressure measurements in mmHg over time and the relation to patient outcomes (including survival)
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 5 May 2015.
- Derived from this study: PubMed 22217879Raimann JG, Usvyat LA, Thijssen S, Kotanko P, Rogus J, Lacson E Jr, Levin NW. Blood pressure stability in hemodialysis patients confers a survival advantage: results from a large retrospective cohort study. Kidney Int. 2012 Mar;81(6):548-58. doi: 10.1038/ki.2011.426. Epub 2012 Jan 4.
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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.
Nathan W Levin, MD principal investigator
Renal Research Institute
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 Renal Disease and High Blood Pressure, run by Renal Research Institute at 1 site in United States.
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 1 inclusion and 0 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 5 May 2015. 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 United States. 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.
What does the primary outcome measure?
Effect size of the relation of dynamic changes of blood pressure (BP) at different ranges of BP to survival in incident hemodialysis patients. (time frame: Up to 11 years and 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01330004, which also lists 1 linked publication.
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 5 May 2015.