Renal DiseaseNCT02501044
Oxygen Desaturation During Hemodialysis
An observational study of Renal Disease and Hypoxia, run by Renal Research Institute at 1 site in United States.
Trial summary
Hemodialysis patients may experience drops in blood oxygen saturation during the hemodialysis treatment, which may lead to hypoxia in the tissues. The investigators hypothesize that: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Disease, Hypoxia
- How many people
- 5,500 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2015
- 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: Renal Research Institute hemodialysis patients
Who may be able to join
- Hemodialysis patient
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxygen Desaturation During Hemodialysis: Clinical Correlates and Association With Adverse Outcomes
Hemodialysis patients may experience drops in blood oxygen saturation during the hemodialysis treatment, which may lead to hypoxia in the tissues.
The investigators hypothesize that:
- The cumulative number, severity, or other characteristics of such deoxygenation episodes may be a predictor of adverse outcomes in hemodialysis patients.
- There may be demographic, anthropometric, clinical, treatment prescription, lab analytical, and other parameters that correlate with the number and severity of deoxygenation episodes and, therefore, may be used for risk stratification. Further, some of these parameters may be modifiable.
- Conditions
- Renal Disease, Hypoxia
- Medical subject headings
- Kidney Diseases, Hypoxia
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.
Cumulative number of deoxygenation episodes
Crit-Line III monitor recordings (which contain oxygen saturation data) will be extracted from the RRI database and the cumulative number of deoxygenation episodes will be analyzed.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startJan 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 5,500 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
- NCT02501044
- Sponsor's protocol ID
- 14-446
- Status last verified
- Jul 2015
- First submitted
- 9 Jul 2015
- Last updated
- 17 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Desaturation During Hemodialysis: Clinical Correlates and Association With Adverse Outcomes
- ClinicalTrials.gov ID
- NCT02501044
- Acronym / sponsor ID
- 14-446
- Conditions
- Renal Disease, Hypoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,500 participants (actual)
- Lead sponsor
- Renal Research InstituteUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Jul 2015 (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.
Hemodialysis patients may experience drops in blood oxygen saturation during the hemodialysis treatment, which may lead to hypoxia in the tissues.
The investigators hypothesize that:
- The cumulative number, severity, or other characteristics of such deoxygenation episodes may be a predictor of adverse outcomes in hemodialysis patients.
- There may be demographic, anthropometric, clinical, treatment prescription, lab analytical, and other parameters that correlate with the number and severity of deoxygenation episodes and, therefore, may be used for risk stratification. Further, some of these parameters may be modifiable.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis Patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Renal Research Institute hemodialysis patients
Key inclusion criteria (1 listed)
- Hemodialysis patient
Key exclusion criteria (1 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
Cumulative number of deoxygenation episodes
Time frame: Up to 36 months
Crit-Line III monitor recordings (which contain oxygen saturation data) will be extracted from the RRI database and the cumulative number of deoxygenation episodes will be analyzed.
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 17 Jul 2015.
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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 Disease and Hypoxia, 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 1 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 17 Jul 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?
Cumulative number of deoxygenation episodes (time frame: Up to 36 months). 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 17 Jul 2015.