End-Stage Renal DiseasePhase 3NCT00150956
Effects of Daily Home Hemodialysis on Circulation, Mental Functions, and Quality of Life
A Phase 3 study testing Daily home hemodialysis in people with End-Stage Renal Disease, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
This study was designed to discover mechanisms responsible for the decrease in (high) blood pressure after starting daily hemodialysis, as has been observed by various investigators. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- Daily home hemodialysis
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 1999to Jan 2002
- Phase
- Phase 3
- 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
Who may be able to join
- End-stage renal disease patients
- Fit and motivated for home hemodialysis
Who cannot join
- Patients, who were treated with frequent dialysis (5 or 6 times a week) before
- Diabetes mellitus
- Severe comorbidity (e.g. malignancies)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
UMC Utrecht, Department of Nephrology & Hypertension
Utrecht, 3584 CX
About this study
Official title: Study Into the Effects of Daily Home Hemodialysis on Hemodynamics, Neurocognitive Functions, and Quality of Life
This study was designed to discover mechanisms responsible for the decrease in (high) blood pressure after starting daily hemodialysis, as has been observed by various investigators. We hypothesized that better control of body water and sodium content and a decline in the autonomic (sympathetic) nervous system activity, increased in chronic renal failure patients, would contribute to improved blood pressure regulation.
Moreover, we studied the effects of daily hemodialysis on mental functions, like information processing and memory, in relation to the previously reported improvement in quality of life, and the effects on nutrition. We hypothesized that all would improve.
Read the detailed description
Although conventional hemodialysis has faced many technical improvements in recent years, a great deal of end-stage renal disease patients, treated with this modality, have suboptimal or high blood pressure, and suffer poor quality of life. Daily hemodialysis has been reported to improve both, but the pathophysiological background is poorly understood.
Patients were studied before and after 6 months of daily (i.e.6 times a week) home hemodialysis, and again after two months of conventional (i.e. thrice weekly) hemodialysis.
We measured the effects of daily dialysis (compared with conventional dialysis) on blood pressure, cardiac output, extracellular fluid volume, plasma renin activity, sympathetic nervous system activity (through MSNA), the electroencephalogram (EEG), neurocognitive functioning (speed of information processing, memory, executive functioning, and attention), quality of life, and nutritional status
- Conditions
- End-Stage Renal Disease
- Being tested
- Daily home hemodialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily home hemodialysisProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure at 6 months
Cardiac output at 6 months
Extracellular fluid volume at 6 months
Plasma renin activity at 6 months
Muscle sympathetic nerve activity (MSNA) at 6 months
Electroencephalogram (EEG) at 6 months
Neurocognitive functioning at 6 months
Quality of life at 6 months
Secondary outcomes (1)
Nutritional status at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startApr 1999
- Study completionJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Dianet Dialysis Centers, Dutch Kidney Foundation
- Investigators
- Pieter F Vos, MD, Principal investigator, UMC Utrecht, Department of Nephrology & Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150956
- Sponsor's protocol ID
- C98-1750
- Other IDs
- Dutch Kidney Foundation
- Status last verified
- Oct 2000
- First submitted
- 6 Sep 2005
- Last updated
- 8 Sep 2005
- Results posted
- No
Publications
Kooistra MP, Vos J, Koomans HA, Vos PF. Daily home haemodialysis in The Netherlands: effects on metabolic control, haemodynamics, and quality of life. Nephrol Dial Transplant. 1998 Nov;13(11):2853-60. doi: 10.1093/ndt/13.11.2853.
PubMed 9829490Vos PF, Zilch O, Kooistra MP. Clinical outcome of daily dialysis. Am J Kidney Dis. 2001 Jan;37(1 Suppl 2):S99-S102. doi: 10.1053/ajkd.2001.20761.
PubMed 11158871
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Into the Effects of Daily Home Hemodialysis on Hemodynamics, Neurocognitive Functions, and Quality of Life
- ClinicalTrials.gov ID
- NCT00150956
- Acronym / sponsor ID
- C98-1750
- Conditions
- End-Stage Renal Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Dianet Dialysis Centers, Dutch Kidney Foundation
- Study start
- Apr 1999
- Study completion
- Jan 2002
- First posted
- 8 Sep 2005 (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 study was designed to discover mechanisms responsible for the decrease in (high) blood pressure after starting daily hemodialysis, as has been observed by various investigators. We hypothesized that better control of body water and sodium content and a decline in the autonomic (sympathetic) nervous system activity, increased in chronic renal failure patients, would contribute to improved blood pressure regulation.
Moreover, we studied the effects of daily hemodialysis on mental functions, like information processing and memory, in relation to the previously reported improvement in quality of life, and the effects on nutrition. We hypothesized that all would improve.
Detailed description
Although conventional hemodialysis has faced many technical improvements in recent years, a great deal of end-stage renal disease patients, treated with this modality, have suboptimal or high blood pressure, and suffer poor quality of life. Daily hemodialysis has been reported to improve both, but the pathophysiological background is poorly understood.
Patients were studied before and after 6 months of daily (i.e.6 times a week) home hemodialysis, and again after two months of conventional (i.e. thrice weekly) hemodialysis.
We measured the effects of daily dialysis (compared with conventional dialysis) on blood pressure, cardiac output, extracellular fluid volume, plasma renin activity, sympathetic nervous system activity (through MSNA), the electroencephalogram (EEG), neurocognitive functioning (speed of information processing, memory, executive functioning, and attention), quality of life, and nutritional status
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- End-stage renal disease patients
- Fit and motivated for home hemodialysis
Key exclusion criteria (3 listed)
- Patients, who were treated with frequent dialysis (5 or 6 times a week) before
- Diabetes mellitus
- Severe comorbidity (e.g. malignancies)
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 |
|---|---|---|
| Daily home hemodialysis | Procedure or surgery | – |
Primary outcome
Blood pressure at 6 months
Cardiac output at 6 months
Extracellular fluid volume at 6 months
Plasma renin activity at 6 months
Muscle sympathetic nerve activity (MSNA) at 6 months
Electroencephalogram (EEG) at 6 months
Neurocognitive functioning at 6 months
Quality of life at 6 months
1 secondary outcome
Nutritional status at 6 months
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 8 Sep 2005.
- Background: PubMed 9829490Kooistra MP, Vos J, Koomans HA, Vos PF. Daily home haemodialysis in The Netherlands: effects on metabolic control, haemodynamics, and quality of life. Nephrol Dial Transplant. 1998 Nov;13(11):2853-60. doi: 10.1093/ndt/13.11.2853.
- Background: PubMed 11158871Vos PF, Zilch O, Kooistra MP. Clinical outcome of daily dialysis. Am J Kidney Dis. 2001 Jan;37(1 Suppl 2):S99-S102. doi: 10.1053/ajkd.2001.20761.
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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.
Pieter F Vos, MD principal investigator
UMC Utrecht, Department of Nephrology & Hypertension
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Daily home hemodialysis in people with End-Stage Renal Disease, run by UMC Utrecht at 1 site in Netherlands.
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 2 inclusion and 3 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 8 Sep 2005. 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 Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Blood pressure at 6 months. The study lists 8 primary outcomes in all. 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 NCT00150956, which also lists 2 linked publications.
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 8 Sep 2005.