Kidney FailureNCT02545920
To Assess Ear Blood Flow During Dialysis
An observational study of Kidney Failure, run by University College, London at 1 site in United Kingdom.
Trial summary
This is a prospective observational pilot study of patients under the care of the Royal Free Hospital with chronic kidney disease who have been established on regular thrice weekly haemodialysis treatments in a dialysis centre,to measure the changes in blood flow in the ear during haemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Failure
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to 30 Aug 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with chronic kidney failure attending for regular dialysis treatment
Who may be able to join
- Patients age 18 years and older up to 80 years
- Under the care of the Royal Free Hospital with chronic kidney disease and established on regular thrice weekly haemodiafiltration.
- Able to provide written informed consent obtained
Who cannot join
- Patients unable to provide written informed consent
- Patients using hearing aids
- Patients who have had previous middle ear surgery
- Patients not fulfilling inclusion criteria
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Free Hospital
London, NW32QG
winnie Han, 442077940500, w.han@ucl.ac.uk
About this study
Official title: Pilot Study to Assess the Effects of Haemodialysis Treatments on Blood Flow to the Ear
This is a prospective observational pilot study of patients under the care of the Royal Free Hospital with chronic kidney disease who have been established on regular thrice weekly haemodialysis treatments in a dialysis centre,to measure the changes in blood flow in the ear during haemodialysis.
Read the detailed description
10 patients, attending for thrice weekly outpatient haemodiafiltration shall be studied during a dialysis session using a CE marked commercially available digital otoscope capable of recording digital videos of the tympanic membrane and ear canal.
Patients will receive standard clinical care and monitoring of their dialysis session, which includes recording of blood pressure and changes in haematocrit and volume status during dialysis and noting patient symptoms.
- Conditions
- Kidney Failure
- Being tested
- no intervention
- Keywords
- haemodialysis, hypotension
- Medical subject headings
- Renal Insufficiency, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
change in ear blood flow
percentage change in ear blood flow compared to initial ear blood flow
Measured: day 1 dialysis session
Secondary outcomes (3)
change in blood pressure
change in blood pressure in mmHg compared to starting blood pressure
Measured: day 1 dialysis session
change in haematocrit volume status
percentage change in haematocrit
Measured: day 1 dialysis session
record of hypotensive episodes during dialysis
record of nursing interventions including reduction in ultrafiltration volume, administration of intravenous fluids. Use of distress thermometer visual analogue scale to record patient symptoms
Measured: day 1 dialysis session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startSep 2015
- Primary completion30 Oct 2020
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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 only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- andrew davenport, Principal investigator, UCL Centre for Nephrology, Royal Free Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545920
- Sponsor's protocol ID
- 15/0310
- Status last verified
- Nov 2020
- First submitted
- 7 Jul 2015
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Effects of Haemodialysis Treatments on Blood Flow to the Ear
- ClinicalTrials.gov ID
- NCT02545920
- Acronym / sponsor ID
- 15/0310
- Conditions
- Kidney Failure
- Keywords
- haemodialysis, hypotension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 10 Sep 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.
This is a prospective observational pilot study of patients under the care of the Royal Free Hospital with chronic kidney disease who have been established on regular thrice weekly haemodialysis treatments in a dialysis centre,to measure the changes in blood flow in the ear during haemodialysis.
Detailed description
10 patients, attending for thrice weekly outpatient haemodiafiltration shall be studied during a dialysis session using a CE marked commercially available digital otoscope capable of recording digital videos of the tympanic membrane and ear canal.
Patients will receive standard clinical care and monitoring of their dialysis session, which includes recording of blood pressure and changes in haematocrit and volume status during dialysis and noting patient symptoms.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic kidney failure attending for regular dialysis treatment
Key inclusion criteria (3 listed)
- Patients age 18 years and older up to 80 years
- Under the care of the Royal Free Hospital with chronic kidney disease and established on regular thrice weekly haemodiafiltration.
- Able to provide written informed consent obtained
Key exclusion criteria (4 listed)
- Patients unable to provide written informed consent
- Patients using hearing aids
- Patients who have had previous middle ear surgery
- Patients not fulfilling inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionobservational study | Other | – |
Primary outcome
change in ear blood flow
Time frame: day 1 dialysis session
percentage change in ear blood flow compared to initial ear blood flow
3 secondary outcomes
change in blood pressure
Time frame: day 1 dialysis session
change in haematocrit volume status
Time frame: day 1 dialysis session
record of hypotensive episodes during dialysis
Time frame: day 1 dialysis session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
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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.
andrew davenport principal investigator
UCL Centre for Nephrology, Royal Free Hospital
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 Kidney Failure, run by University College, London at 1 site in United Kingdom.
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 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: status not confirmed, as of the sponsor's last update on 4 Nov 2020. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact vashist deelchand (02077940500, vashist.deelchand@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in ear blood flow (time frame: day 1 dialysis session). 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 4 Nov 2020.