None listed
Conditions
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.
Interventions
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.
Sponsors
Royal Brisbane and Women's Hospital
Study design
Allocation
Randomised controlled trial
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 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
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.
Outcome results
None listed