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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)

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 )

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000076077
Acronym
Timely PD study
Enrollment
122
Registered
2010-01-20
Start date
2008-09-15
Completion date
2013-05-09
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 randomi

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.

Sponsors

Queensland Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 31, 2026