Renal FailureNCT01454193
Are we Loading Our Patients With Sodium During Hemodialysis Treatments?
An observational study of Renal Failure, run by Renal Research Institute at 1 site in United States.
Trial summary
The objectives of the data search is to find out if there is correlation between pre, post serum sodium concentration, dialysate sodium concentration, interdialytic weight gain and associated changes in pre and post systolic and diastolic blood pressure, mean arterial pressure, number of blood pressure medications and… Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Renal Failure
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Oct 2011
- 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: Hemodialysis patients at Renal Research Institute and Fresenius clinics
Who may be able to join
- Hemodialysis patient
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of the data search is to find out if there is correlation between pre, post serum sodium concentration, dialysate sodium concentration, interdialytic weight gain and associated changes in pre and post systolic and diastolic blood pressure, mean arterial pressure, number of blood pressure medications and adherence to 3 times per week dialysis, mortality.
- Conditions
- Renal Failure
- Medical subject headings
- Renal Insufficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startJan 2001
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies 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
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renal Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Kotanko, MD, Principal investigator, Renal Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454193
- Sponsor's protocol ID
- 078-08
- Status last verified
- Oct 2011
- First submitted
- 13 Oct 2011
- Last updated
- 19 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are we Loading Our Patients With Sodium During Hemodialysis Treatments?
- ClinicalTrials.gov ID
- NCT01454193
- Acronym / sponsor ID
- 078-08
- Conditions
- Renal Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Renal Research InstituteUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 18 Oct 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.
The objectives of the data search is to find out if there is correlation between pre, post serum sodium concentration, dialysate sodium concentration, interdialytic weight gain and associated changes in pre and post systolic and diastolic blood pressure, mean arterial pressure, number of blood pressure medications and adherence to 3 times per week dialysis, mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients at Renal Research Institute and Fresenius clinics
Key inclusion criteria (1 listed)
- Hemodialysis patient
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
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 19 Oct 2011.
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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.
Peter Kotanko, 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 Failure, 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 19 Oct 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 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.
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 19 Oct 2011.