ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610000076077

Ethics application status

Approved

Date submitted

18/01/2010

Date registered

20/01/2010

Date last updated

2/03/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Randomised Controlled Trial to determine the appropriate time to initiate peritoneal dialysis after insertion of catheter to minimise complications in end stage renal disease patients (Timely Peritoneal dialysis study)

Scientific title

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

N/A

Trial acronym

Timely PD study

Linked study record

Health condition

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

Chroinc kidney disease complications

Condition category

Condition code

Renal and Urogenital

Kidney disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

1. All patients who met the inclusion and exclusion criteria and who underwent surgical peritoneal dialysis (PD) catheter insertion at the Royal Brisbane and Women’s Hospital (RBWH) and Rockhampton Base Hospital (RKH ) are invited to participate in the study. These participants were not on PD before and will be starting PD for the first time.
2. Tenckhoff curled PD catheters are inserted by the same surgical teams ( general surgery consultant /team) at each centre.

Participants were randomised to PD initiation interval, Group 1 (G1) commenced PD at one week, group 2 (G2) at two and group 3 (G3) at four weeks after insertion of PD catheter. Participants were also stratified by diabetic status.
All participants received formal PD training. Participants initiated PD with similar patterns of clinical practice apart from the randomised varying PD intervals. The PD catheter exit site and tunnel were examined according to standard clinical practice.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Control Group is 2 weeks

Control group

Active

Outcomes

Primary outcome [1]

Peritoneal fluid leaks and infection (over the four weeks following start up of peritoneal dialysis; Leak by observation during clinical examination; infection by chemical analysis of peritoneal dialysis fluid )

Timepoint [1]

4 weeks from initiation of dialysis

Secondary outcome [1]

Composite of all PD catheter related complications such as infection at exit site by clinical observation and will be confirmed by microbiological tests.

Timepoint [1]

8 weeks from catheter insertion

Secondary outcome [2]

Hemodialysis related complications such as infection and catheter related complications. These complications will be assessed by clinical examination/ tests

Timepoint [2]

8 weeks from PD catheter insertion

Eligibility

Key inclusion criteria

1. end stage kidney disease
2. patients likely to start peritoneal dialysis in the 4 weeks after insertion of a Tenckhoff catheter
4.surgical or peritoneoscopic insertion of a Tenckhoff catheter
5.18 yrs or over
6. able to give informed consent

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 4 weeks ) acute infection.
3. patients in whom peritoneal dialysis 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)

Participants are randomised to different arms . The participants are block randomised in equal proportions
to the three treatment groups using randomly
varying blocks The randomisation
sequence was generated using Stata 11 software .
Group 1 will start dialysis one week after Tenckhoff catheter
insertion, group 2 at two weeks and group 3 at four
weeks. A research nurse independent of study nurses and
physicians will undertake randomisation process.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation sequence was generated using Stata 11 software

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Participants will be stratified by site and diabetic status

Phase

Not Applicable

Type of endpoint/s

Safety

Statistical methods / analysis

To obtain 80% power with
an overall 1-sided significance level of 0.05, approximately
105 patients are required per group to establish
non-inferiority, defined as a difference in complication
rates less than 10% between two groups. It was assumed
that the expected complication rate was 3% as estimated
from the preliminary data, and the significance level was
adjusted for multiple comparisons.
Interim analysis was done

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

15/09/2008

Actual

15/09/2008

Date of last participant enrolment

Anticipated

31/12/2013

Actual

9/05/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

315

Accrual to date

Final

122

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Queensland Health

Address [1]

Royal Brisbane & Women's Hospitals,Butterfield Street Herston ,Queensland,4029

Country [1]

Australia

Primary sponsor type

Hospital

Name

Queensland Health

Address

Department of Renal Medicine
Level 9 ,Ned Hanlon Building ,Butterfield street, Herston,Queensland,4029

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Baxter Clinical Educational Council

Address [1]

Renal Division
Baxter Healthcare Corporation
T: +1.450.226.3273 direct
T: +1.847.473.6193 McGaw Park
M: +1.450.240.5330
F: +1.847.473.6903

Country [1]

United States of America

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane and women's Hospitals Research and Ethics Committee

Ethics committee address [1]

Level 7, Block 7
Royal Brisbane and Women's Hospital
HERSTON QLD 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/10/2007

Approval date [1]

02/02/2008

Ethics approval number [1]

HREC/RBWH/ 2007/171

Summary

Brief summary

The planned study targets patients with end stage kidney disease who choose peritoneal dialysis for maintenance therapy. Current practice at the Royal Brisbane and Women's Hospital is to wait four weeks after a Teckhoff catheter is placed before starting peritoneal dialysis . The literature lacks evidence of the optimal interval between peritoneal catheter insertion and start up of dialysis.  Consequently practice varies. They too support delayed use but do not test different delay intervals and can not tell us the optimal time. A few recent studies reported a very low leak incidence after using catheter 1 week post insertion , attributed to a tight catheter securing. Any delay in starting PD results in temporary haemodialysis in patients who require immediate dailysis.  Temporary haemodialysis requires a central venous access with attendant risk of complications.  Temporary haemodialysis is more expensive than peritoneal dialysis . Therefore guidelines bodies, such as CARI (Caring for Australasians with Renal Impairment,), European Dialysis and Transplant Association-European Renal Association and  International Society for Peritoneal Dialysis suggest a two week delay. They can  can only publish suggestions based on the weak body of evidence, or lack thereof. CARI suggests randomised control trial as there is insufficient evidence for this to be a “guideline’’.
The primary objective of this study is to determine the safest and shortest time interval between surgical placement of a Tenckhoff catheter and starting dialysis.  The hypothesis is that there is no difference in complication rates between one, two and four week time intervals. If equivalence is proven between one, two and four week time intervals, we could justifiably change practice.  Benefits for future patients include shorter exposure to haemodialysis treatments and their complications and shorter duration of haemodialysis catheter placement and its complications.  If the results show more complications in the one or two week time interval groups, then we would encourage re-visiting the guidelines. catheter placement and its complications.

Trial website

Trial related presentations / publications

Trial has been published at BMC Nephrology 

Ranganathan D, Baer R,  Fassett R, Williams N,., Watson M, Han T and Healy.H
Randomised Controlled Trail to Determine the appropriate time to initiate peritoneal Dialysis 
Ranganathan D et al , BMC Nephrology 2010,11.11

Public notes

Contacts

Principal investigator

Name

Dr Dwarakanathan Ranganathan

Address

Department of Renal Medicine
Royal Brisbane & Women's Hospital
Butterfield Street
Herston QLD 4029

Country

Australia

Phone

+61736468576

Fax

dwarakanathan.ranganathan@health.qld.gov.au

Contact person for public queries

Name

Dr Dwarakanathan Ranganathan

Address

Senior Consultant Nephrologist
Royal brisbane & Women's Hospitals
Herston. Queensland, 4029

Country

Australia

Phone

+61 -07-36368576

Fax

+61- 07-36368572

dwarakanathan.ranganathan@health.qld.gov.au

Contact person for scientific queries

Name

Dr Dwarakanathan Ranganathan

Address

Senior Consultant Nephrologist
Royal brisbane &women's Hospitals
Herston. Queensland, 4029

Country

Australia

Phone

+61736468576

Fax

+61736468572

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

Source	Title	Year of Publication	DOI
Dimensions AI	Randomised Controlled Trial to determine the appropriate time to initiate peritoneal dialysis after insertion of catheter to minimise complications (Timely PD study)	2010	https://doi.org/10.1186/1471-2369-11-11
Embase	A randomized controlled trial to determine the appropriate time to initiate peritoneal dialysis after insertion of catheter (Timely PD study).	2017	https://dx.doi.org/10.3747/pdi.2016.00066

N.B. These documents automatically identified may not have been verified by the study sponsor.

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