Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000006347
Ethics application status
Approved
Date submitted
31/12/2007
Date registered
8/01/2008
Date last updated
22/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Dialysis exchange free treatment for peritonitis in peritoneal dialysis ( a safety trial)
Scientific title
Use of Icodextrin® Dialysate with an exchange free period in the initial treatment of peritoneal dialysis associated peritonitis: A Pilot Study
Secondary ID [1] 283060 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
peritonitis 2660 0
peritoneal dialysis 2661 0
Condition category
Condition code
Renal and Urogenital 2780 2780 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
dialysis exchange free interval in peritoneal dialysis patients presenting with peritonitis , use of Intraperitoneal Icodextrin (2500mls of 7.5%) for dialysis in conjunction with dry exchanges for 2 days post peritonitis onset. thereafter patients continue as per standard treatment.Intraperitoneal antibiotics are added to one exhange /day.
Intervention code [1] 2402 0
Treatment: Other
Comparator / control treatment
standard treatment
Peritoneal dialysis involving 3- 5 exchanges/day with intraperitoneal glucose containing solutions of either 1.5%, 2.5%or 4.25% (1.5L.2l ,2.5L or 3ldepending on the patients regular dialysis prescription) for 2 weeks post peritonitis onset. Follow up is for 2 weeks post peritonitis onset. Intraperitoneal antibiotics are added to one exhange /day.
Control group
Active

Outcomes
Primary outcome [1] 3666 0
Time to resolution of peritonitis
Timepoint [1] 3666 0
14 days
Primary outcome [2] 3667 0
removal of Tenchkoff catheters.
Timepoint [2] 3667 0
14days
Secondary outcome [1] 6190 0
relapse of peritonitis
Timepoint [1] 6190 0
4 weeks
Secondary outcome [2] 6191 0
serum urea and creatinine by lab testing
Timepoint [2] 6191 0
14 days
Secondary outcome [3] 6192 0
ultrafiltration capacity- by weighing the peritoneal effluent.
Timepoint [3] 6192 0
14 days
Secondary outcome [4] 6193 0
death
Timepoint [4] 6193 0
3 months
Secondary outcome [5] 6194 0
technique failure by documenting transfer to haemodialysis
Timepoint [5] 6194 0
3 months
Secondary outcome [6] 6195 0
hospitalization
Timepoint [6] 6195 0
14 days
Secondary outcome [7] 6196 0
Monitoring of systemic and peritoneal markers of inflammation and fibrosis by blodd and peritoneal fluid testing.
Timepoint [7] 6196 0
14 days

Eligibility
Key inclusion criteria
Age 18 years or over
Ability to give informed consent
Diagnosis of End stage renal disease
Subjects on Peritoneal dialysis for at least a month and has had a baseline PET study.
Prevalent patients on peritoneal dialysis presenting with peritonitis (Dialysate white cell count- WCC > 100cells/HPF and > 50% polymorphonuclear leukocytes PMNL)
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with a severe mental disability or psychiatric disorder that interferes with their ability to give informed consent and /or comply with study procedures.
Diabetic patients requiring insulin or using non-glucose oxidase based systems (Advantage) for blood sugar monitoring.
Female subjects who are pregnant, lactating or planning to become pregnant.
Note: female subjects of childbearing potential must not be pregnant or lactating and must be using a medically acceptable means of contraception.
Peritonitis in the previous month.
Subjects unable to receive inraperitoneal antibiotics for the treatment of their peritonitis.
Previous hypersensitivity to Icodextrin®
Subjects who have glycogen storage disease
Subjects with maltose or isomaltose intolerance
Chronically underdialysed patients with the most recent serum urea =35 mmol/l and a serum potassium = 5.8mmol/l.
Subjects with mean arterial blood pressure (MAP) = 150 mm Hg on presentation.
Subjects who have ongoing clinically significant congestive heart failure (New York heart Association Class III or IV)
Subjects with concomitant participation in any other interventional study affecting PD solution prescription.
Subjects who have any medical condition that, in the judgement of the investigators, would jeopardise the patient’s safety following exposure to the study drug or in the judgement of the investigators will not be able to tolerate the procedure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/02/2008
Actual
3/02/2010
Date of last participant enrolment
Anticipated
Actual
3/03/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 716 0
New Zealand
State/province [1] 716 0
Auckland

Funding & Sponsors
Funding source category [1] 2920 0
Hospital
Name [1] 2920 0
A+ Trust fund
Country [1] 2920 0
New Zealand
Primary sponsor type
Hospital
Name
A+ Trust fund
Address
A+ Trust Office

Level 15

ACH Support Building
Private bag 92024
Auckland
Country
New Zealand
Secondary sponsor category [1] 2637 0
Commercial sector/Industry
Name [1] 2637 0
Baxter healthcare limited
Address [1] 2637 0
33 Vestey Drive
Mt Wellington Auckland
Country [1] 2637 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4862 0
Northern X Regional Ethics Committee
Ethics committee address [1] 4862 0
Ministry of Health
3rd Floor, Unisys Building
650 Great South Rd, Penrose
Private bag 92522, Wellesley Street Auckland
Ethics committee country [1] 4862 0
New Zealand
Date submitted for ethics approval [1] 4862 0
09/10/2007
Approval date [1] 4862 0
03/12/2007
Ethics approval number [1] 4862 0
NTX/07/10/103

Summary
Brief summary
During peritoneal dialysis fluid is repeatedly recycled in the abdomen, to get rid of excess fluid and waste products. Peritonitis or infection of the lining inside the abdomen is a serious complication in dialysis patients that can sometimes result in death, hospitalisation or withdrawal of peritoneal dialysis. We add antibiotics to the dialysis fluid which then dwell inside the abdomen.
The dialysis process interferes with the ability of the body to localise infection and depletes useful factors formed to fight it. Icodextrin® is a product that can provide superior dialysis to the traditional dextrose based product that is used in our units, especially so with fluid removal during peritonitis episodes. It is our aim to utilise the superior dialytic properties of Icodextrin® in the first 60 hours following a peritonitis episode with a dialysis free period of up to 12 hours to allow the body sufficient time to contain the infection and also to allow sufficient build up of the factors of immunity to overcome the infection. We want to show that this procedure is equivalent in safety to the traditional treatment we use and is associated with less inflammation in the peritoneum and blood of patients.
Trial website
Trial related presentations / publications
poster presentation International Society of peritoneal dialysis kuala Lumpur 09/09/2012
In Press . Peritoneal dialysis International
Public notes

Contacts
Principal investigator
Name 28264 0
Dr Maha Yehia
Address 28264 0
Auckland City Hospital
Private Bag 92024
Auckland
Country 28264 0
New Zealand
Phone 28264 0
006421737276
Fax 28264 0
Email 28264 0
[email protected]
Contact person for public queries
Name 11421 0
Dr Dr. Maha Yehia
Address 11421 0
Department of Renal Medicine
Level 15- support Building
Auckland City Hospital
Private Bag 92024
Auckland
Country 11421 0
New Zealand
Phone 11421 0
006421737276
Fax 11421 0
006493074987
Email 11421 0
[email protected]
Contact person for scientific queries
Name 2349 0
Dr Dr. Maha Yehia
Address 2349 0
Department of Renal Medicine
Level 15- support Building
Auckland City Hospital
Private Bag 92024
Auckland
Country 2349 0
New Zealand
Phone 2349 0
006421737276
Fax 2349 0
006493074987
Email 2349 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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