PeritonitisPhase 4NCT01044446
Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients During Acute Peritonitis
A Phase 4 study testing Icodextrin and glucose-based peritoneal dialysate in people with Peritonitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The objective of the present study is to evaluate the a prior hypothesis that treatment with icodextrin during acute peritonitis would improve the treatment outcomes of peritonitis complicating peritoneal dialysis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Peritonitis
- What is being tested?
- Icodextrin and glucose-based peritoneal dialysate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2010to Apr 2013
- Phase
- Phase 4
- 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
Who may be able to join
- aged 18 or older on peritoneal dialysis, who develop clinical evidence of peritonitis
- stable peritoneal dialysis with Baxter connection system
- willingness to give written consent and comply with the study protocol
Who cannot join
- already on icodextrin dialysate prior to acute presentation with peritonitis
- known allergy or hypersensitivity to icodextrin, starch or have a glycogen storage disease
- participation in another interventional study within last 30 days of randomization
- history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the study procedures
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Prince of Wales Hospital, Chinese University of Hong Kong
Shatin, New Territories, SAR
About this study
Official title: Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients
The objective of the present study is to evaluate the a prior hypothesis that treatment with icodextrin during acute peritonitis would improve the treatment outcomes of peritonitis complicating peritoneal dialysis. The safety and effectiveness of icodextrin for decreasing glucose exposure, extent and severity of peritonitis will be evaluated in the setting of acute peritonitis complicating peritoneal dialysis among patients who are not receiving icodextrin.
- Conditions
- Peritonitis
- Being tested
- Icodextrin, glucose-based peritoneal dialysate
- Keywords
- peritoneal dialysis, peritonitis, CAPD, end-stage renal disease, peritonitis outcome and ultrafiltration
- Medical subject headings
- Peritonitis, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcodextrinDrug
one exchange daily
glucose-based peritoneal dialysateDrug
original exchange frequency
| Study group | Role | What they receive |
|---|---|---|
| Icodextrin | Experimental | peritoneal dialysate Receives: Drug: Icodextrin |
| Glucose-based dialysate | Active comparator | peritoneal dialysate Receives: Drug: glucose-based peritoneal dialysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
peritoneal dialysate total white cell count on day 3 of acute peritonitis
Measured: day 3
Secondary outcomes (1)
need of additional hypertonic exchanges, ultrafiltration volumes according to patient diary, fluid control as denoted by changes in body weight, and the timing of peritonitis resolution
Measured: within the period of peritonitis treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2012
- Study completionApr 2013
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 PeritonitisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chow Kai Ming, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044446
- Sponsor's protocol ID
- CRE-2009.481
- Status last verified
- Aug 2016
- First submitted
- 6 Jan 2010
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Chow KM, Szeto CC, Kwan BC, Pang WF, Ma T, Leung CB, Law MC, Li PK. Randomized controlled study of icodextrin on the treatment of peritoneal dialysis patients during acute peritonitis. Nephrol Dial Transplant. 2014 Jul;29(7):1438-43. doi: 10.1093/ndt/gfu033. Epub 2014 Feb 26.
PubMed 24578470
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT01044446
- Acronym / sponsor ID
- CRE-2009.481
- Conditions
- Peritonitis
- Keywords
- peritoneal dialysis, peritonitis, CAPD, end-stage renal disease, peritonitis outcome and ultrafiltration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 Jan 2010 (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.
The objective of the present study is to evaluate the a prior hypothesis that treatment with icodextrin during acute peritonitis would improve the treatment outcomes of peritonitis complicating peritoneal dialysis. The safety and effectiveness of icodextrin for decreasing glucose exposure, extent and severity of peritonitis will be evaluated in the setting of acute peritonitis complicating peritoneal dialysis among patients who are not receiving icodextrin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Icodextrin | Experimental | Drug: Icodextrinperitoneal dialysate |
| Glucose-based dialysate | Active comparator | Drug: glucose-based peritoneal dialysateperitoneal dialysate |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 or older on peritoneal dialysis, who develop clinical evidence of peritonitis
- stable peritoneal dialysis with Baxter connection system
- willingness to give written consent and comply with the study protocol
Key exclusion criteria (4 listed)
- already on icodextrin dialysate prior to acute presentation with peritonitis
- known allergy or hypersensitivity to icodextrin, starch or have a glycogen storage disease
- participation in another interventional study within last 30 days of randomization
- history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the study procedures
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 |
|---|---|---|
| Icodextrinone exchange daily | Drug | Icodextrin |
| glucose-based peritoneal dialysateoriginal exchange frequency | Drug | Glucose-based dialysate |
Primary outcome
peritoneal dialysate total white cell count on day 3 of acute peritonitis
Time frame: day 3
1 secondary outcome
need of additional hypertonic exchanges, ultrafiltration volumes according to patient diary, fluid control as denoted by changes in body weight, and the timing of peritonitis resolution
Time frame: within the period of peritonitis treatment
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 10 Aug 2016.
- Derived from this study: PubMed 24578470Chow KM, Szeto CC, Kwan BC, Pang WF, Ma T, Leung CB, Law MC, Li PK. Randomized controlled study of icodextrin on the treatment of peritoneal dialysis patients during acute peritonitis. Nephrol Dial Transplant. 2014 Jul;29(7):1438-43. doi: 10.1093/ndt/gfu033. Epub 2014 Feb 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Icodextrin and glucose-based peritoneal dialysate in people with Peritonitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 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: finished, as of the sponsor's last update on 10 Aug 2016. 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 Hong Kong. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
peritoneal dialysate total white cell count on day 3 of acute peritonitis (time frame: day 3). 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 NCT01044446, 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 10 Aug 2016.