Fluid StatusNCT00801112
Bioimpedance as a Tool for Fluid Management in Peritoneal Dialysis (PD) Patients
An observational study of Fluid Status and Peritoneal Dialysis, run by University Hospital of North Staffordshire at 1 site in United Kingdom.
Trial summary
Hypothesis: The investigators hypothesize that regular monitoring of BIA adds value to the management of fluid status in PD patients Objectives of the study: The objective is to show that in patients where the additional information of body composition is available to the clinician that the ECFv is maintained within… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Fluid Status, Peritoneal Dialysis
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2009to Jan 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Incident and prevalent PD patients.
Who may be able to join
- All PD patients who are clinically stable
Who cannot join
- Patients planning discontinuation of PD within 6 months.
- Patients who are unable to give consent.
- Patients who have peritonitis the last 30 days prior to study enrollment.
- Patients who are pregnant.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital of North Staffordshire
Stoke-on-Trent, Staffordshire, ST4 7LN
Simon J Davies, MD FRCP, +44(0)1782 554164, simondavies1@compuserve.com
Kay B Tan, MB MRCP, +44(0)1782 554185, tanbkay@doctors.org.uk
About this study
Official title: Developing Bioimpedance (BIA) as a Tool for Fluid Management in Peritoneal Dialysis Patients: A Validation Study
Hypothesis: The investigators hypothesize that regular monitoring of BIA adds value to the management of fluid status in PD patients
Objectives of the study: The objective is to show that in patients where the additional information of body composition is available to the clinician that the ECFv is maintained within pre-agreed limits, ~ 1 liter, over the observation period of 12 months.
Read more
SCIENTIFIC BACKGROUND:
Low peritoneal ultrafiltration, and by inference low sodium removal, is associated with worse outcomes in PD. Equally, excessive fluid removal is a risk factor for dehydration and loss of residual renal function. Current guidelines have advocated a daily UF volume of 1litre; their blunt application could lead to either inappropriate early loss of residual function or modality transfer. There is a significant need for evidence on how to best manage fluid status in PD patients, both in terms of an appropriate clinical strategy and also a simple but reproducible tool to guide clinicians in how to apply this strategy.
It is likely that BIA will become the standard tool to aid clinicians in assessing fluid status. It is simple to perform, intervention studies have demonstrated its ability to identify changes in fluid status in response to changes in therapy and it is a powerful predictor of patient survival. There is, however a clear need at this stage for proof of principle studies to establish its true potential for added value in the routine management of patients.
Body composition changes spontaneously with time on PD. Short term changes in hydration (specifically extracellular fluid volume, ECFv) combined with medium term changes in muscle and fat make it difficult for the clinician to be sure if fluid status is stable. It is anticipated that regular BIA measurements will aid the clinician in managing this problem over and above monitoring of weight and fluid status. By randomizing patients into two groups who have regular BIA measurements, one of which the BIA data is available to the clinician it will be possible to see if these spontaneous changes in body composition can be accounted for.
- Conditions
- Fluid Status, Peritoneal Dialysis
- Keywords
- Bioimpedance, Fluid status, Peritoneal Dialysis, Extra-cellular fluid volume
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 |
|---|---|---|
| 1 | PD patients with residual renal function >200ml with BIA monitor. | |
| 2 | PD patients with residual renal function <200ml with BIA monitor. | |
| 3 | PD patients with residual renal function >200ml without BIA monitor | |
| 4 | PD patients with residual renal function <200ml without BIA monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extra-cellular Fluid Volume (ECFv) determined from BIA to be maintained within pre-agreed limit of 1 liter.
Measured: 12 months
Secondary outcomes (1)
Blood pressure control and residual urine volume.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startJan 2009
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid StatusStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Staffordshire
- Sponsor type
- University, hospital or other
- Collaborators
- St. James's Hospital, Ireland, Sheffield Teaching Hospitals NHS Foundation Trust
- Investigators
- Simon J Davies, MD FRCP, Principal investigator, University Hospital of North Staffordshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801112
- Sponsor's protocol ID
- BIA-001MC
- Status last verified
- Dec 2008
- First submitted
- 2 Dec 2008
- Last updated
- 3 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Bioimpedance (BIA) as a Tool for Fluid Management in Peritoneal Dialysis Patients: A Validation Study
- ClinicalTrials.gov ID
- NCT00801112
- Acronym / sponsor ID
- BIA-001MC
- Conditions
- Fluid Status, Peritoneal Dialysis
- Keywords
- Bioimpedance, Fluid status, Peritoneal Dialysis, Extra-cellular fluid volume
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital of North StaffordshireUniversity, hospital or other
- Collaborators
- St. James's Hospital, Ireland, Sheffield Teaching Hospitals NHS Foundation Trust
- Study start
- Jan 2009
- Study completion
- Jan 2011 (estimated)
- First posted
- 3 Dec 2008 (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.
Hypothesis: The investigators hypothesize that regular monitoring of BIA adds value to the management of fluid status in PD patients
Objectives of the study: The objective is to show that in patients where the additional information of body composition is available to the clinician that the ECFv is maintained within pre-agreed limits, ~ 1 liter, over the observation period of 12 months.
SCIENTIFIC BACKGROUND:
Low peritoneal ultrafiltration, and by inference low sodium removal, is associated with worse outcomes in PD. Equally, excessive fluid removal is a risk factor for dehydration and loss of residual renal function. Current guidelines have advocated a daily UF volume of 1litre; their blunt application could lead to either inappropriate early loss of residual function or modality transfer. There is a significant need for evidence on how to best manage fluid status in PD patients, both in terms of an appropriate clinical strategy and also a simple but reproducible tool to guide clinicians in how to apply this strategy.
It is likely that BIA will become the standard tool to aid clinicians in assessing fluid status. It is simple to perform, intervention studies have demonstrated its ability to identify changes in fluid status in response to changes in therapy and it is a powerful predictor of patient survival. There is, however a clear need at this stage for proof of principle studies to establish its true potential for added value in the routine management of patients.
Body composition changes spontaneously with time on PD. Short term changes in hydration (specifically extracellular fluid volume, ECFv) combined with medium term changes in muscle and fat make it difficult for the clinician to be sure if fluid status is stable. It is anticipated that regular BIA measurements will aid the clinician in managing this problem over and above monitoring of weight and fluid status. By randomizing patients into two groups who have regular BIA measurements, one of which the BIA data is available to the clinician it will be possible to see if these spontaneous changes in body composition can be accounted for.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –PD patients with residual renal function >200ml with BIA monitor. |
| 2 | – | –PD patients with residual renal function <200ml with BIA monitor. |
| 3 | – | –PD patients with residual renal function >200ml without BIA monitor |
| 4 | – | –PD patients with residual renal function <200ml without BIA monitor |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Incident and prevalent PD patients.
Key inclusion criteria (1 listed)
- All PD patients who are clinically stable
Key exclusion criteria (4 listed)
- Patients planning discontinuation of PD within 6 months.
- Patients who are unable to give consent.
- Patients who have peritonitis the last 30 days prior to study enrollment.
- Patients who are pregnant.
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
Extra-cellular Fluid Volume (ECFv) determined from BIA to be maintained within pre-agreed limit of 1 liter.
Time frame: 12 months
1 secondary outcome
Blood pressure control and residual urine volume.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2008.
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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.
Simon J Davies, MD FRCP principal investigator
University Hospital of North Staffordshire
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 Fluid Status and Peritoneal Dialysis, run by University Hospital of North Staffordshire 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 1 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 3 Dec 2008. 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 Simon J Davies, MD FRCP (+44(0)1782 554164, simondavies1@compuserve.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extra-cellular Fluid Volume (ECFv) determined from BIA to be maintained within pre-agreed limit of 1 liter. (time frame: 12 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 3 Dec 2008.