Risk Reduction
Conditions
Keywords
peritoneal dialysis
Brief summary
Since the emergence of home peritoneal dialysis as an alternative to in-center hemodialysis for chronic renal replacement therapy in the late 1970s, the percentage of dialysis patients on PD has continued to decrease each year. There have been a growing concern and research on patient and technique survival of peritoneal dialysis versus hemodialysis to find influential factors for better clinical outcomes. Meanwhile, technique failure rates were significantly higher in small centers treating less than twenty five PD patients. And there was a result for better technique survival after the second year, among the patients trained at the BREC(Baxter Renal Education Center). Better technique survival in large centers can be assumed with not only their more experience with patient management but also their educational infrastructure compared to small-sized centers. Throughout our experiences in the last 30 years, we have recognized that a major element of PD program is patient training, however few data are available in terms of the relationship between PD training and treatment outcome and mostly are retrospective and non-randomized. Moreover, the technique survival and patient survival were analyzed with no significant difference. From the insight, we decided to study prospectively to evaluate the efficacy of well-structured education program in terms of various patient outcomes in incident patients on PD.
Detailed description
This study will be conducted as multi-center, open-label, randomized, controlled trial. One hundred four patient starting PD will be randomized into two training groups. Patients in the conventional training group (CG) will be given non-standardized in-center conventional training programs plus two sessions of training by home visit, while those in intensive training group (IG) given in-center conventional training programs plus repeated home visits regularly over 24-month period (total thirteen visits). The primary end point of the study is exit site infection (ESI). Secondary endpoints are peritonitis and all-cause infection. Generalized Estimating Equations will be used to assess the adjusted effect of training level on the ESI and Cox regression model employed to evaluate the effect on the peritonitis and other secondary outcomes.
Interventions
BEHAVIORALIntensive training group
an extra structured patient centric training program on PD technique and diet according to the developed training curriculum
Sponsors
Baxter Healthcare Corporation
Kook-Hwan Oh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Incident patients who have PD catheter insertion for starting PD with Baxter solutions * \> 20 yr of age
Exclusion criteria
* Patients who have undergone dialysis or received kidney transplant (note, however, that patients who are currently undergoing emergency hemodialysis temporarily right before the PD do not fall under the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exit site infection | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of ESIs per patient-month | 24 months |
| Days of hospitalization per year | 24 months |
| Systolic pressure and diastolic pressure measured at every visit | 24 months |
| Average number of antihypertensive medications | 24 months |
| Kt/V | 24 months |
| Residual renal function | 24 months |
| Fluid balance score | 24 months |
| Patient survival rate | 24 months |
| Total medical cost | 24 months |
| Total hours of education and training | 24 months |
| Unplanned home visit and education by peritoneal dialysis nurse | 24 months |
| time to the first peritonitis | 24 months |
| HbA1c only for patients with diabetes | 24 months |
| Intact PTH level | 24 months |
| Hemoglobin level | 24 months |
| nPNA | 24 months |
| QOL | 24 months |
| SGA | 24 months |
| K level | 24 months |
| Total number of hospitalizations by cause over the last 1 and/or 2 years after the dialysis | 24 months |
| Technical survival rate | 24 months |
| peritonitis rate | 24 months |
| Compliance score of patients | 24 months |
Countries
South Korea
Outcome results
None listed