End Stage Renal DiseaseHOPE-02NCT04623281
Haemodialysis Outcomes & Patient Empowerment Study 02
An observational study of End Stage Renal Disease and Dialysis; Complications, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial summary
Pilot-scale, single-arm,observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients compared with bioimpedance and haemodialysis machine data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Dialysis; Complications, Volume Overload
- What is being tested?
- Sixty device
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- 21 Jan 2021to 15 Jun 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 years and older
- All sexes
- Adult, Older adult
Study population: Require maintenance haemodialysis in an ambulatory care setting. Study will be conducted in a single centre in a tertiary hospital. Patients with a range of baseline fluid statuses will be considered for enrollment.
Who may be able to join
- On haemodialysis in an ambulatory care setting.
- Demonstrates understanding of correct use of the Sixty device.
- Capable and willing to measure blood pressure at home on a daily basis.
- Willing to give written informed consent.
Who cannot join
- Conditions precluding use of bioimpedance (e.g. Implantable Cardioverter Defibrillator, pacemakers, hearing aids, pregnancy).
- Significant confusion or any concomitant medical condition, which would limit the ability of the patient to record symptoms or other parameters.
Trial locations and contacts
1 site in 1 country.
About this study
Pilot-scale, single-arm,observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients compared with bioimpedance and haemodialysis machine data.
Read the detailed description
Pilot-scale, single-arm,observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients compared with bioimpedance and haemodialysis machine data.
The Sixty device uses diffuse reflectance spectroscopy to measure fluid status.
20 patients will be assessed during the study observation period.
10 patients undergo an observation period of approximately three weeks. The patients will be asked to wear the Sixty device during dialysis and at night throughout the study observation period.
Following the completion of this 3 week observation period, an additional 10 patients will wear the Sixty device as per the protocol for 3 weeks.
Haemodialysis parameters will be assessed as usual during the study.
Bioimpedance measurements will be taken pre and post-dialysis once weekly during the mid-week dialysis session:
Patient-reported symptoms related to haemodialysis will be recorded, including symptoms of hypervolaemia and hypovolaemia.
- Being tested
- Sixty device
- Keywords
- Sensor, Volume Overload, Dialysis, Bioimpedance
- Medical subject headings
- Kidney Failure, Chronic, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sixty deviceDevice
Prototype wearable hydration monitor to be worn by patient during dialysis and at night
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Observational group of 10 haemodialysis patients following usual care for 3 weeks. Receives: Device: Sixty device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Sixty device versus bioimpedance
The primary endpoint will be to evaluate the accuracy of the Sixty device data in assessing volume in haemodialysis patients compared to bioimpedance
Bioimpedance measurements will be performed using the Fresenius Body Composition Monitor (BCM)
Measured: 3 weeks
Secondary outcomes (5)
Comparison of changes in volume status as determined by Sixty device versus fluid removed per unit of time during haemodialysis session
Fluid removed (mls/ unit of time)
Measured: 3 weeks
Comparison of changes in volume status as determined by Sixty device versus blood pressure
Blood pressure (mmHg)
Measured: 3 weeks
Comparison of changes in volume status as determined by Sixty device versus change in weight pre and post dialysis
Weight (kg)
Measured: 3 weeks
Comparison of changes in volume status as determined by Sixty device versus change in blood volume monitoring
Blood volume monitoring: Relative blood volume (%)
Measured: 3 weeks
Acceptability of Sixty device
The patient's opinion of the acceptability of the Sixty device as assessed by their response to a questionnaire.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start21 Jan 2021
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
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 End Stage 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Beaumont Hospital, patientMpower Ltd., Design to Value Ltd, Enterprise Ireland
- Responsible party
- Sponsor
- Investigators
- Renal Dialysis Centre, Beaumont Hospital, Principal investigator, RCSI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623281
- Sponsor's protocol ID
- HOPE-02
- Acronym
- HOPE-02
- Status last verified
- Oct 2020
- First submitted
- 23 Oct 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sandys V, Edwards C, McAleese P, O'Hare E, O'Seaghdha C. Protocol of a pilot-scale, single-arm, observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients. Pilot Feasibility Stud. 2022 Jan 24;8(1):17. doi: 10.1186/s40814-022-00976-7.
PubMed 35073985
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemodialysis Outcomes & Patient Empowerment Study 02
- ClinicalTrials.gov ID
- NCT04623281
- Acronym / sponsor ID
- HOPE-02 / HOPE-02
- Keywords
- Sensor, Volume Overload, Dialysis, Bioimpedance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- Beaumont Hospital, patientMpower Ltd., Design to Value Ltd, Enterprise Ireland
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 10 Nov 2020 (actual)
- 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.
Pilot-scale, single-arm,observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients compared with bioimpedance and haemodialysis machine data.
Detailed description
Pilot-scale, single-arm,observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients compared with bioimpedance and haemodialysis machine data.
The Sixty device uses diffuse reflectance spectroscopy to measure fluid status.
20 patients will be assessed during the study observation period.
10 patients undergo an observation period of approximately three weeks. The patients will be asked to wear the Sixty device during dialysis and at night throughout the study observation period.
Following the completion of this 3 week observation period, an additional 10 patients will wear the Sixty device as per the protocol for 3 weeks.
Haemodialysis parameters will be assessed as usual during the study.
Bioimpedance measurements will be taken pre and post-dialysis once weekly during the mid-week dialysis session:
Patient-reported symptoms related to haemodialysis will be recorded, including symptoms of hypervolaemia and hypovolaemia.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Device: Sixty deviceObservational group of 10 haemodialysis patients following usual care for 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Require maintenance haemodialysis in an ambulatory care setting. Study will be conducted in a single centre in a tertiary hospital. Patients with a range of baseline fluid statuses will be considered for enrollment.
Key inclusion criteria (4 listed)
- On haemodialysis in an ambulatory care setting.
- Demonstrates understanding of correct use of the Sixty device.
- Capable and willing to measure blood pressure at home on a daily basis.
- Willing to give written informed consent.
Key exclusion criteria (2 listed)
- Conditions precluding use of bioimpedance (e.g. Implantable Cardioverter Defibrillator, pacemakers, hearing aids, pregnancy).
- Significant confusion or any concomitant medical condition, which would limit the ability of the patient to record symptoms or other parameters.
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 |
|---|---|---|
| Sixty devicePrototype wearable hydration monitor to be worn by patient during dialysis and at night | Device | Observational group |
Primary outcome
Accuracy of Sixty device versus bioimpedance
Time frame: 3 weeks
The primary endpoint will be to evaluate the accuracy of the Sixty device data in assessing volume in haemodialysis patients compared to bioimpedance Bioimpedance measurements will be performed using the Fresenius Body Composition Monitor (BCM)
5 secondary outcomes
Comparison of changes in volume status as determined by Sixty device versus fluid removed per unit of time during haemodialysis session
Time frame: 3 weeks
Comparison of changes in volume status as determined by Sixty device versus blood pressure
Time frame: 3 weeks
Comparison of changes in volume status as determined by Sixty device versus change in weight pre and post dialysis
Time frame: 3 weeks
Comparison of changes in volume status as determined by Sixty device versus change in blood volume monitoring
Time frame: 3 weeks
Acceptability of Sixty device
Time frame: 3 weeks
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 Sep 2021.
- Derived from this study: PubMed 35073985Sandys V, Edwards C, McAleese P, O'Hare E, O'Seaghdha C. Protocol of a pilot-scale, single-arm, observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients. Pilot Feasibility Stud. 2022 Jan 24;8(1):17. doi: 10.1186/s40814-022-00976-7.
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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.
Renal Dialysis Centre, Beaumont Hospital principal investigator
RCSI
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 End Stage Renal Disease and Dialysis; Complications, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
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 4 inclusion and 2 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 Sep 2021. 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 Ireland. 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?
Accuracy of Sixty device versus bioimpedance (time frame: 3 weeks). 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 NCT04623281, 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 Sep 2021.