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Retraining for prevention of peritonitis in peritoneal dialysis patients: A randomized controlled trial
Susanne Ljungman1, Jørgen E Jensen2, Dag Paulsen3
1Department of Nephrology, Sahlgrenska University Hospital, Gothenburg, Sweden.
Insights
Regular testing and retraining did not reduce peritonitis in peritoneal dialysis (PD) patients. This study found no significant difference in infection rates, suggesting current methods may not be effective for all PD patients.
Area of Science:
- Nephrology
- Infectious Disease Prevention
- Clinical Trials
Background:
- Peritonitis is a common complication in peritoneal dialysis (PD).
- Patient adherence to PD exchange protocols is crucial for preventing peritonitis.
- Nonadherence is linked to a higher incidence of peritonitis compared to compliant patients.
Purpose of the Study:
- To evaluate if regular testing of PD knowledge, focusing on infection prophylaxis, can improve outcomes.
- To determine if this intervention increases the time to the first peritonitis episode.
- To assess if the intervention reduces the overall peritonitis rate in new PD patients.
Main Methods:
- An open-label, parallel-group randomized controlled trial involving new peritonitis-free PD patients.
- Patients were randomized to either a control group or a retraining group receiving knowledge and skills testing.
- Testing and retraining occurred at multiple intervals post-PD initiation over 36 months.
Main Results:
- No significant difference was observed between groups in the cumulative incidence of first peritonitis.
- The peritonitis rate per patient year did not differ significantly between the control and retraining groups.
- Study groups showed similar outcomes despite the intervention, with high discontinuation rates in both.
Conclusions:
- Regular, targeted testing and retraining of PD patients did not demonstrate a significant benefit in preventing peritonitis.
- The study was underpowered and included low-risk patients, potentially limiting the ability to detect an effect.
- Contamination between groups and susceptibility to statistical errors were noted limitations.
Background:
Peritonitis is more common in peritoneal dialysis (PD) patients nonadherent to the PD exchange protocol procedures than in compliant patients. We therefore investigated whether regular testing of PD knowledge with focus on infection prophylaxis could increase the time to first peritonitis (primary outcome) and reduce the peritonitis rate in new PD patients.
Methods:
This physician-initiated, open-label, parallel group trial took place at 57 centers in Sweden, Denmark, Norway, Finland, Estonia, Latvia, the Netherlands, and the United Kingdom from 2010 to 2015. New peritonitis-free PD patients were randomized using computer-generated numbers 1 month after the start of PD either to a control group (n = 331) treated according to center routines or to a retraining group (n = 340), which underwent testing of PD knowledge and skills at 1, 3, 6, 12, 18, 24, 30, and 36 months after PD start, followed by retraining if the goals were not achieved.
Results:
In all, 74% of the controls and 80% of the retraining patients discontinued the study. The groups did not differ significantly regarding cumulative incidence of first peritonitis adjusted for competing risks (kidney transplantation, transfer to hemodialysis and death; hazard ratio 0.84; 95% confidence interval (CI) 0.65-1.09) nor regarding peritonitis rate per patient year (relative risk 0.93; 95% CI 0.75-1.16).
Conclusions:
In this randomized controlled trial, we were unable to demonstrate that regular, targeted testing and retraining of new PD patients increased the time to first peritonitis or reduced the rate of peritonitis, as the study comprised patients with a low risk of peritonitis, was underpowered, open to type 1 statistical error, and contamination between groups.
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