Haemodialysis ComplicationNCT03851185
Combining Bioimpedance and Blood Volume Measurements in Haemodialysis
An observational study of Haemodialysis Complication, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Around 60,000 patients in the UK are being treated for severe kidney failure. The most common treatment is haemodialysis (HD). An important part of HD is removing extra fluid from the body which the kidneys normally remove in urine. Deciding how much fluid to remove is not easy. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Haemodialysis Complication
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Feb 2019to 31 Mar 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those receiving haemodialysis
Who may be able to join
- Ultrafiltration volumes in the preceding two weeks of less than 0.5 litres;
- pre-HD BCM-measured OH <1.1 litres; pre-HD blood pressure <140/90.
- Cohort 2 - High BMI group: This group is intended to represent patients with high BMI who routinely finish dialysis with significant fluid depletion, as defined by BCM, without intradialytic symptoms.
- BMI>30 with target weight > 1.1 kg below normally hydrated weight;
- no recorded symptoms related to fluid removal in the preceding 2 weeks.
- Cohort 3 - Low LTI group: This group is intended to represent patients who have a low LTI and who routinely finish dialysis with a degree of excess fluid as defined by BCM.
Show all 9Show fewer
- LTI < 10kg/m2 with target weight > 1.1 kg above normally hydrated weight.
- Cohort 4 - Localised oedema group: This group is intended to represent patients who have localised lower limb oedema.
- Oedema as defined by pitting
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St James's University Hospitals NHS Trust
Leeds, LS9 7TF
David Keane, 01132064119, david.keane@nhs.net
About this study
Official title: Individualised Fluid Management in Haemodialysis: Combining Bioimpedance and Absolute Blood Volume Measurements for Improved Clinical Effectiveness and Patient Experience
Around 60,000 patients in the UK are being treated for severe kidney failure. The most common treatment is haemodialysis (HD). An important part of HD is removing extra fluid from the body which the kidneys normally remove in urine. Deciding how much fluid to remove is not easy. It is normally based on clinical signs, such as blood pressure or tissue swollen with fluid, but there is a need for better tests to help guide these decisions.
Bioimpedance tests are one way of measuring fluid status. They involve passing a small electric current through tissue using stickers on the skin. The test is portable, cheap, simple, painless and harmless. One bioimpedance device, the Body Composition Monitor (BCM), has been designed particularly for kidney patients. However the BCM measures fluid in the whole body and cannot tell us how much fluid is in the blood (the blood volume), which has the biggest effect on patients' health.
Read more
The aim of this study is to see whether blood volume measurements can help to make fluid management more individualised. This could reduce the impact of dialysis on patients' health and improve patients' experience of the treatment.
Objective 1: To demonstrate whether the addition of blood volume measurements can help to tailor fluid management to HD patients' individual needs. In particular we will look at how body size, nutritional state, age and localised fluid can affect patients' blood volume.
Objective 2: To see if there is a simple way of making blood volume measurements with no need for expertise or extra equipment.
It is planned to recruit 40 patients into 4 clinically different groups and compare results between them.
The results will be compared between groups to help us understand how decisions about fluid management can be tailored to keep blood volume at the optimal level.
- Conditions
- Haemodialysis Complication
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of post-dialysis blood volume (ABV) in the high BMI group.
Absolute blood volume measurements: ABV measurements will be made based on the infusion of ultra-pure dialysate into the extracorporeal blood circuit and the analysis of the effect of the dilution on RBV.
Measured: 10 mins
Measurement of post-dialysis blood volume (ABV) in the low lean tissue index (LTI) cohort
Absolute blood volume measurements: ABV measurements will be made based on the infusion of ultra-pure dialysate into the extracorporeal blood circuit and the analysis of the effect of the dilution on RBV.
Measured: 10 Mins
Measurement of post-dialysis blood volume (ABV) in the localised oedema cohort
Absolute blood volume measurements: ABV measurements will be made based on the infusion of ultra-pure dialysate into the extracorporeal blood circuit and the analysis of the effect of the dilution on RBV.
Measured: 10 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start15 Feb 2019
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemodialysis ComplicationStudies 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
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851185
- Sponsor's protocol ID
- RL18/109517
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 28 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualised Fluid Management in Haemodialysis: Combining Bioimpedance and Absolute Blood Volume Measurements for Improved Clinical Effectiveness and Patient Experience
- ClinicalTrials.gov ID
- NCT03851185
- Acronym / sponsor ID
- RL18/109517
- Conditions
- Haemodialysis Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 22 Feb 2019 (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.
Around 60,000 patients in the UK are being treated for severe kidney failure. The most common treatment is haemodialysis (HD). An important part of HD is removing extra fluid from the body which the kidneys normally remove in urine. Deciding how much fluid to remove is not easy. It is normally based on clinical signs, such as blood pressure or tissue swollen with fluid, but there is a need for better tests to help guide these decisions.
Bioimpedance tests are one way of measuring fluid status. They involve passing a small electric current through tissue using stickers on the skin. The test is portable, cheap, simple, painless and harmless. One bioimpedance device, the Body Composition Monitor (BCM), has been designed particularly for kidney patients. However the BCM measures fluid in the whole body and cannot tell us how much fluid is in the blood (the blood volume), which has the biggest effect on patients' health.
The aim of this study is to see whether blood volume measurements can help to make fluid management more individualised. This could reduce the impact of dialysis on patients' health and improve patients' experience of the treatment.
Objective 1: To demonstrate whether the addition of blood volume measurements can help to tailor fluid management to HD patients' individual needs. In particular we will look at how body size, nutritional state, age and localised fluid can affect patients' blood volume.
Objective 2: To see if there is a simple way of making blood volume measurements with no need for expertise or extra equipment.
It is planned to recruit 40 patients into 4 clinically different groups and compare results between them.
The results will be compared between groups to help us understand how decisions about fluid management can be tailored to keep blood volume at the optimal level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those receiving haemodialysis
Key inclusion criteria (9 listed)
- Ultrafiltration volumes in the preceding two weeks of less than 0.5 litres;
- pre-HD BCM-measured OH <1.1 litres; pre-HD blood pressure <140/90.
- Cohort 2 - High BMI group: This group is intended to represent patients with high BMI who routinely finish dialysis with significant fluid depletion, as defined by BCM, without intradialytic symptoms.
- BMI>30 with target weight > 1.1 kg below normally hydrated weight;
- no recorded symptoms related to fluid removal in the preceding 2 weeks.
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
Measurement of post-dialysis blood volume (ABV) in the high BMI group.
Time frame: 10 mins
Absolute blood volume measurements: ABV measurements will be made based on the infusion of ultra-pure dialysate into the extracorporeal blood circuit and the analysis of the effect of the dilution on RBV.
Measurement of post-dialysis blood volume (ABV) in the low lean tissue index (LTI) cohort
Time frame: 10 Mins
Absolute blood volume measurements: ABV measurements will be made based on the infusion of ultra-pure dialysate into the extracorporeal blood circuit and the analysis of the effect of the dilution on RBV.
Measurement of post-dialysis blood volume (ABV) in the localised oedema cohort
Time frame: 10 mins
Absolute blood volume measurements: ABV measurements will be made based on the infusion of ultra-pure dialysate into the extracorporeal blood circuit and the analysis of the effect of the dilution on RBV.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 Haemodialysis Complication, run by The Leeds Teaching Hospitals NHS Trust 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 9 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: status not confirmed, as of the sponsor's last update on 28 Feb 2019. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of post-dialysis blood volume (ABV) in the high BMI group. (time frame: 10 mins). The study lists 3 primary outcomes in all. 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 28 Feb 2019.