Randomised Controlled Trial to determine the appropriate time to initiate peritoneal dialysis after insertion of catheter to minimise complications (Timely PD study)

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Abstract

Background

The most appropriate time to initiate dialysis after surgical 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 immediate with delayed use. The primary objective is to determine the safest and shortest time interval between surgical placement of a Tenckhoff catheter and starting PD.

Methods/Design

This is a randomised controlled trial of patients who will start PD after insertion of Tenckhoff catheter at Royal Brisbane and Women's Hospital (RBWH) or Rockhampton Base Hospital (RBH) who meet the inclusion criteria. Patients will be stratified by site and diabetic status. The patients will be randomised to one of three treatment groups. Group 1 will start PD one week after Tenckhoff catheter insertion, group 2 at two weeks and group 3 at four weeks. 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.

Discussion

The study will determine the most appropriate time to initiate PD after placement of a Tenckhoff catheter.

Trial Registration

ACTRN12610000076077

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Most cited references 10

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Vascular access and all-cause mortality: a propensity score analysis.

Emily Atkins, Kevan Polkinghorne, Michael P. McDonald … (2004)

The native arteriovenous fistula (AVF) is the preferred vascular access because of its longevity and its lower rates of infection and intervention. Recent studies suggest that the AVF may offer a survival advantage. Because these data were derived from observational studies, they are prone to potential bias. The use of propensity scores offers an additional method to reduce bias resulting from nonrandomized treatment assignment. Adult (age 18 yr or more) patients who commenced hemodialysis in Australia and New Zealand on April 1, 1999, until March 31, 2002, were studied by using the Australian and New Zealand Dialysis and Transplant Association (ANZDATA) Registry. Cox regression was used to determine the effect of access type on total mortality. Propensity scores were calculated and used both as a controlling variable in the multivariable model and to construct matched cohorts. The catheter analysis was stratified by dialysis duration at entry to ANZDATA to satisfy the proportional-hazard assumption. There were 612 deaths in 3749 patients (median follow-up, 1.07 yr). After adjustment for confounding factors and propensity scores, catheter use was predictive of mortality. Patients with arteriovenous grafts (AVG) also had a significantly increased risk of death. Effect estimates were also consistent in the smaller propensity score-matched cohorts. Both AVG and catheter use in incident hemodialysis patients are associated with significant excess of total mortality. Reducing catheter use and increasing the proportion of patients commencing hemodialysis with a mature AVF remain important clinical objectives.

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Immediate initiation of CAPD following percutaneous catheter placement without break-in procedure.

Young-Il Jo, Sug Kyun Shin, Jong Ho Lee … (2015)

To evaluate the effect of a modified method of percutaneous catheter placement without a break-in procedure on the development of catheter-related complications in patients on continuous ambulatory peritoneal dialysis (CAPD). A prospective, observational clinical study. Peritoneal dialysis (PD) units of two university-based hospitals. This study included 51 consecutive patients on CAPD. A straight double-cuffed Tenckhoff catheter with a straight intraperitoneal segment was used, and all catheters were inserted using a modified percutaneous placement method under local anesthesia. The catheter was introduced directly into the deep pelvis through an intramuscular tract, which had been created by tapered dilators. Peritoneal dialysis was initiated immediately after catheter insertion without a break-in procedure. Catheter-related complications were surveyed during the 12 months after initiation of CAPD. Within the first month, only 1 pericatheter leakage (1.9%) was detected. There were no cases of visceral perforation or severe hemorrhage during catheter insertions. Catheter malfunction due to catheter tip migration, exit-site infection, and peritonitis developed in only 1.9%, 3.9%, and 3.9% of patients, respectively. After 1 month following catheter insertion, no further incidences of pericatheter leakage occurred during the follow-up period. All catheters, except one that was reinserted due to tip migration, survived throughout the study period. The rates of pericatheter leakage and other catheter-related complications are relatively low in CAPD patients using our percutaneous catheter placement method without a break-in procedure. This procedure is comparatively simple and less invasive than other catheter placement methods, and allows for immediate start of PD after catheter insertion, without a break-in procedure.

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Dialysate leaks in peritoneal dialysis.

M. LeBlanc, D Ouimet, V Pichette (2015)

Dialysate leakage represents a major noninfectious complication of peritoneal dialysis (PD). An exit-site leak refers to the appearance of any moisture around the PD catheter identified as dialysate; however, the spectrum of dialysate leaks also includes any dialysate loss from the peritoneal cavity other than via the lumen of the catheter. The incidence of dialysate leakage is somewhat more than 5% in continuous ambulatory peritoneal dialysis (CAPD) patients, but this percentage probably underestimates the number of early leaks. The incidence of hydrothorax or pleural leak as a complication of PD remains unclear. Factors identified as potentially related to dialysate leakage are those related to the technique of PD catheter insertion, the way PD is initiated, and weakness of the abdominal wall. The pediatric literature tends to favor Tenckhoff catheters over other catheters as being superior with respect to dialysate leakage, but no consensus on catheter choice exists for adults in this regard. An association has been found between early leaks (< or =30 days) and immediate CAPD initiation and perhaps median catheter insertion. Risk factors contributing to abdominal weakness appear to predispose mostly to late leaks; one or more of them can generally be identified in the majority of patients. Early leakage most often manifests as a pericatheter leak. Late leaks may present more subtly with subcutaneous swelling and edema, weight gain, peripheral or genital edema, and apparent ultrafiltration failure. Dyspnea is the first clinical clue to the diagnosis of a pleural leak. Late leaks tend to develop during the first year of CAPD. The most widely used approach to determine the exact site of the leakage is with computed tomography after infusion of 2 L of dialysis fluid containing radiocontrast material. Treatments for dialysate leaks include surgical repair, temporary transfer to hemodialysis, lower dialysate volumes, and PD with a cycler. Recent recommendation propose a standard approach to the treatment of early and late dialysate leaks: 1-2 weeks of rest from CAPD, and surgery if recurrence. Surgical repair has been strongly suggested for leakage causing genital swelling. Delaying CAPD for 14 days after catheter insertion may prevent early leakage. Initiating CAPD with low dialysate volume has also been recommended as a good practice measure. Although peritonitis and exit-site infections are the most frequent causes of technical failure in peritoneal dialysis (PD), dialysate leaks represent one of the major noninfectious complications of PD. In some instances, dialysate leakage may lead to discontinuation of the technique (1). Despite its importance, the incidence, risk factors, management, and outcome of dialysate leakage are poorly characterized in the literature. We will review the limited available information on this topic in the next few sections.

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Author and article information

Journal

Journal ID (nlm-ta): BMC Nephrol

Title: BMC Nephrology

Publisher: BioMed Central

ISSN (Electronic): 1471-2369

Publication date Collection: 2010

Publication date (Electronic): 22 June 2010

Volume: 11

Page: 11

Affiliations

[1 ]Renal Medicine, Royal Brisbane and Women's Hospital, Brisbane, Queensland, 4029, Australia

[2 ]Renal Medicine, Cairns Base Hospital, Cairns, Queensland, 4870, Australia

[3 ]School of Medicine, The University of Queensland, Brisbane, Queensland, 4027 Australia

[4 ]School of Human Movement Studies, The University of Queensland, Brisbane, Queensland, 4027, Australia

[5 ]Renal Medicine, Rockhampton Base Hospital, Rockhampton, Queensland, 4700, Australia

[6 ]Statistical Analysis Unit, Health Statistics Centre, Queensland Health, Queensland, 4000, Australia

Article

Publisher ID: 1471-2369-11-11

DOI: 10.1186/1471-2369-11-11

PMC ID: 2898765

PubMed ID: 20565984

SO-VID: 3fec13ef-9419-4318-a46b-ecc01ab3c9e2

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Randomised Controlled Trial to determine the appropriate time to initiate peritoneal dialysis after insertion of catheter to minimise complications (Timely PD study)

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Abstract

Background

Methods/Design

Discussion

Trial Registration

Related collections

Karger: Nephrology

Most cited references 10

Vascular access and all-cause mortality: a propensity score analysis.

Immediate initiation of CAPD following percutaneous catheter placement without break-in procedure.

Dialysate leaks in peritoneal dialysis.

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