Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001553460
Ethics application status
Approved
Date submitted
8/11/2016
Date registered
10/11/2016
Date last updated
10/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial to compare initiation of peritoneal dialysis at one or two weeks post radiological catheter insertion
Scientific title
Randomised Controlled Trial to compare initiation of peritoneal dialysis at one or two weeks post radiological catheter insertion
Secondary ID [1] 290494 0
None
Universal Trial Number (UTN)
Trial acronym
RadCath Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peritoneal Dialysis 300882 0
Chronic Kidney Disease 300883 0
Condition category
Condition code
Renal and Urogenital 300700 300700 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - Participants will have peritoneal dialysis initiated at 1 (+/- 2 days) week post catheter insertion
Arm 2 - Participants will have peritoneal dialysis initiated at 2 (+/- 2 days) weeks post catheter insertion
The intervention will be delivered in the renal unit under trained nursing staff.
The progress will be reviewed on a regular basis during the dialysis sessions and at clinic appointments.
Intervention code [1] 296351 0
Treatment: Other
Comparator / control treatment
The control group is arm 2 which will have their dialysis commenced at the standard time of 2 weeks.
Control group
Active

Outcomes
Primary outcome [1] 300119 0
Peritoneal Fluid Leaks will be assessed by physical exam
Timepoint [1] 300119 0
Within 180 days of peritoneal dialysis catheter insertion
Primary outcome [2] 300120 0
PD related infection - Exit site and/or tunnel and/or peritonitis will be assessed by physical exam, skin swab, blood cultures and or peritoneal fluid microscopy/culture/stain.
Timepoint [2] 300120 0
Within 180 days of peritoneal dialysis catheter insertion
Secondary outcome [1] 329103 0
Composite of all PD catheter related complications and Haemodialysis (HD) requirements and associated complications. PD catheter related complications include fluid leaks, infection, cuff erosion, cuff extrusion, failure to establish PD successfully (may be due to blockage, fibrin plug or outflow obstruction), delayed wound healing, haematoma, catheter revision or replacement, conversion to HD, HD related events, allergic reactions, hospitalisation for any reason with cause recorded as related to either surgery or start-up of dialysis, and death during the study period. The secondary outcomes will be assessed by physical exam and review of medical records.
Timepoint [1] 329103 0
Outcomes will be recorded for 180 days post PD catheter insertion

Eligibility
Key inclusion criteria
1. End Stage Kidney Disease
2. Patients in whom PD is the dialysis modality of preference
3. Patients already on haemodialysis and/or require dialysis initiation within 2 weeks of PD catheter insertion
4. Age >18
5. Able to give informed consent
6. Participants must be scheduled for radiological Tenckhoff catheter insertion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with a history of psychological illness or condition which interferes with their ability to understand or comply with the requirements of the study.
2. Recent (within 1 month) acute infection.
3. Patients in whom PD is contraindicated or not desired.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
224
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 294911 0
Hospital
Name [1] 294911 0
Royal Brisbane and Women's Hospital
Country [1] 294911 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 293745 0
None
Name [1] 293745 0
Address [1] 293745 0
Country [1] 293745 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296290 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [1] 296290 0
Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Ethics committee country [1] 296290 0
Australia
Date submitted for ethics approval [1] 296290 0
25/01/2016
Approval date [1] 296290 0
04/05/2016
Ethics approval number [1] 296290 0
HREC/16/QRBW/19

Summary
Brief summary
Dialysis is the artificial replacement of a patient’s non-functioning kidney which has been damaged due to medical disease. There are two main techniques, peritoneal dialysis (PD) and haemodialysis (HD). PD requires the insertion of a catheter into the patient’s abdomen prior to use. Historically this has been done surgically, however a new technique is for it to be inserted radiologically, which appears to have several benefits including decreased waiting times, inpatient admissions and hospital expenses. The main purpose of this trial is to determine the optimal time to use these catheters post radiological insertion which no study has previously investigated.
The most appropriate time to initiate dialysis after radiological insertion of Tenckhoff catheters is not clear in the literature. There is the possibility of peritoneal dialysis (PD) complications such as leakage and infection if dialysis is started too soon after insertion. However, much morbidity and expense could be saved by reducing dependency on haemodialysis (HD) by earlier initiation of PD post catheter insertion. Previous studies are observational and mostly compare surgically inserted catheters and their immediate or delayed use. The primary objective is to determine the safest and shortest time interval between radiological placement of a Tenckhoff catheter and starting PD.
The goal is to compare initiation of PD at one and two weeks post radiological Tenckhoff catheter insertion. This will be done by measuring the incidence of PD complications in a period post PD commencement as well as the HD associated problems during the same period if bridging HD is performed.
This is a randomised controlled trial of patients who will start PD after radiological insertion of a Tenckhoff catheter at Royal Brisbane and Women’s Hospital (RBWH) and who meet the inclusion criteria. The patients will be randomised to one of two treatment groups. Group 1 will start PD 7 +/-2 days after Tenckhoff catheter insertion and group 2 at 14 +/-2 days. Nurses and physicians will be blinded to the randomised allocation. The primary end point is the complication rate (leaks and infection) after initiation of PD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70282 0
Dr Nigel Mott
Address 70282 0
Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029 Australia
Country 70282 0
Australia
Phone 70282 0
+61 407657121
Fax 70282 0
Email 70282 0
[email protected]
Contact person for public queries
Name 70283 0
Dr Dwarakanathan Ranganathan
Address 70283 0
Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029 Australia
Country 70283 0
Australia
Phone 70283 0
+61 7 36468576
Fax 70283 0
Email 70283 0
[email protected]
Contact person for scientific queries
Name 70284 0
Dr Dwarakanathan Ranganathan
Address 70284 0
Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029 Australia
Country 70284 0
Australia
Phone 70284 0
+61 7 36468576
Fax 70284 0
Email 70284 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.