ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

RadCath Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Peritoneal Dialysis

Chronic Kidney Disease

Condition category

Condition code

Renal and Urogenital

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]

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]

Peritoneal Fluid Leaks will be assessed by physical exam

Timepoint [1]

Within 180 days of peritoneal dialysis catheter insertion

Primary outcome [2]

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]

Within 180 days of peritoneal dialysis catheter insertion

Secondary outcome [1]

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]

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?

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]

Hospital

Name [1]

Royal Brisbane and Women's Hospital

Address [1]

Butterfield St & Bowen Bridge Rd, Herston QLD 4029

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane and Women's Hospital HREC

Ethics committee address [1]

Butterfield St & Bowen Bridge Rd, Herston QLD 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/01/2016

Approval date [1]

04/05/2016

Ethics approval number [1]

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

Dr Nigel Mott

Address

Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029 Australia

Country

Australia

Phone

+61 407657121

Fax

Nigel.Mott@health.qld.gov.au

Contact person for public queries

Name

Dwarakanathan Ranganathan

Address

Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029 Australia

Country

Australia

Phone

+61 7 36468576

Fax

dwarakanathan.ranganathan@health.qld.gov.au

Contact person for scientific queries

Name

Dwarakanathan Ranganathan

Address

Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029 Australia

Country

Australia

Phone

+61 7 36468576

Fax

dwarakanathan.ranganathan@health.qld.gov.au

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.

Trial Review

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