Peritoneal DialysisNCT00119990
Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis
A study testing Icodextrin (dialysate) and Physioneal (dialysate) 1.36% and 2.27% in people with Peritoneal Dialysis, run by University of Aarhus at 1 site in Denmark.
Trial summary
During peritoneal dialysis, water is removed from the body. This sometimes occurs at rates of up to 500 ml/h. During shifts with dialysate with high glucose content, an increase in blood pressure has been described. The effect upon central hemodynamics is unknown. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peritoneal Dialysis
- What is being tested?
- Icodextrin (dialysate) and Physioneal (dialysate) 1.36% and 2.27%
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2006to Jan 2010
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peritoneal dialysis patients
Who cannot join
- Insulin dependent diabetes mellitus
- AV-fistula, cardial arrhythmia persistence, or severe cardiac and lung disease
- Recent infectious disease
- Severe psychiatric disease
- Hypersensitivity to icodextrin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis; the Effect of Different Dialysates
During peritoneal dialysis, water is removed from the body. This sometimes occurs at rates of up to 500 ml/h. During shifts with dialysate with high glucose content, an increase in blood pressure has been described. The effect upon central hemodynamics is unknown. The researchers are investigating the effects of low and high glucose dialysate and icodextrin on cardiac output, stroke volume, pulse rate and blood pressure. The researchers have hypothesized that the effects seen are induced by vasopressin.
- Conditions
- Peritoneal Dialysis
- Being tested
- Icodextrin (dialysate), Physioneal (dialysate) 1.36% and 2.27%
- Keywords
- vasopressin, icodextrin, cardiac output
- Medical subject headings
- Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icodextrin (dialysate)Drug
2 liter of extraneal are given with one fill for 4 hours.
Physioneal (dialysate) 1.36% and 2.27%Drug
2 liter of Physioneal of 1.36% or 3.86% are given with one fill for 4 hours one two different days.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardiac hemodynamics. (Cardiac Output, stroke volume, pulse rate, blood pressure and total peripheral resistance)
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study startJan 2006
- Primary completionJan 2009 (estimated)
- Study completionJan 2010 (estimated)
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 Peritoneal DialysisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Per Ivarsen, Principal investigator, Department of Renal Medicine C, Skejby Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119990
- Sponsor's protocol ID
- AA20050009
- Status last verified
- Dec 2008
- First submitted
- 5 Jul 2005
- Last updated
- 8 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Boon D, Bos WJ, van Montfrans GA, Krediet RT. Acute effects of peritoneal dialysis on hemodynamics. Perit Dial Int. 2001 Mar-Apr;21(2):166-71.
PubMed 11330561
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis; the Effect of Different Dialysates
- ClinicalTrials.gov ID
- NCT00119990
- Acronym / sponsor ID
- AA20050009
- Conditions
- Peritoneal Dialysis
- Keywords
- vasopressin, icodextrin, cardiac output
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 14 Jul 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.
During peritoneal dialysis, water is removed from the body. This sometimes occurs at rates of up to 500 ml/h. During shifts with dialysate with high glucose content, an increase in blood pressure has been described. The effect upon central hemodynamics is unknown. The researchers are investigating the effects of low and high glucose dialysate and icodextrin on cardiac output, stroke volume, pulse rate and blood pressure. The researchers have hypothesized that the effects seen are induced by vasopressin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Peritoneal dialysis patients
Key exclusion criteria (5 listed)
- Insulin dependent diabetes mellitus
- AV-fistula, cardial arrhythmia persistence, or severe cardiac and lung disease
- Recent infectious disease
- Severe psychiatric disease
- Hypersensitivity to icodextrin
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 |
|---|---|---|
| Icodextrin (dialysate)2 liter of extraneal are given with one fill for 4 hours. | Drug | – |
| Physioneal (dialysate) 1.36% and 2.27%2 liter of Physioneal of 1.36% or 3.86% are given with one fill for 4 hours one two different days. | Drug | – |
Primary outcome
Changes in cardiac hemodynamics. (Cardiac Output, stroke volume, pulse rate, blood pressure and total peripheral resistance)
Time frame: 4 hours
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2008.
- Background: PubMed 11330561Boon D, Bos WJ, van Montfrans GA, Krediet RT. Acute effects of peritoneal dialysis on hemodynamics. Perit Dial Int. 2001 Mar-Apr;21(2):166-71.
Related trials for Peritoneal Dialysis
Not yet recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
Not yet recruiting
Iodine Starch Test Use in Pleuroperitoneal Leak
Peritoneal Dialysis, Peritoneal Dialysis (PD)
RecruitingPhase 2
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
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.
Per Ivarsen principal investigator
Department of Renal Medicine C, Skejby Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Icodextrin (dialysate) and Physioneal (dialysate) 1.36% and 2.27% in people with Peritoneal Dialysis, run by University of Aarhus at 1 site in Denmark.
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 5 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: stopped early, as of the sponsor's last update on 8 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 Denmark. 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 was stopped early. Results are not available in the source record.
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?
Changes in cardiac hemodynamics. (Cardiac Output, stroke volume, pulse rate, blood pressure and total peripheral resistance) (time frame: 4 hours). 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 NCT00119990, 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 8 Dec 2008.