Improving the Outcomes of Peritoneal Dialysis (PD) Catheter Insertion
试验速览
- 阶段
- 不适用
- 入组人数
- 2,320
- 试验地点
- 1
- 主要终点
- Insertion related complications
研究概览
简要总结
Peritoneal dialysis (PD) is actively promoted as the preferred form of dialysis for patients with kidney failure. However, 1 in 5 patients will experience a signification catheter insertion-related PD catheter complication in the first 6 months following insertion. Little is known about the patient-, operator-, and center-level factors that influence PD catheter complications. There is a need to identify key modifiable practices to focus randomized trials and quality improvement efforts. We will leverage prior funding, a custom-built data collection platform, pilot data, and a group of engaged stakeholders, partners, and knowledge users to: a) Determine if method of insertion is associated with PD catheter complications b) Identify operator/center characteristics and practices associated with PD catheter complications c) Use a data-driven approach to achieve expert consensus on optimal practices for PD catheter insertion and care.
详细描述
Patient population and setting. We will identify all patients undergoing their first PD catheter insertion during the study period, at 20 participating centers in Canada and the USA (see Appendix 1). A total of 800 cases have been captured to date during our pilot study and an additional 1,520 cases will be accrued over a 30-month period, for a total sample size of 2,320 PD catheter insertions. We will attempt to collect information about consecutive patients undergoing PD catheter attempts/insertions in order to accurately measure local performance. However if a waiver of consent cannot be obtained at participating centers, then non-consecutive patients will be enrolled.
Inclusion criteria: patients must be 18 years of age or older; have advanced chronic kidney disease; have chosen PD as their intended treatment modality; and undergone their first PD catheter placement during the study period.
Exclusion criteria: patients who intend to transfer to another PD program or who are scheduled to receive a transplant within 3 months of the start of PD therapy will be excluded. Data source: ISPD Catheter Registry. The ISPD Catheter Registry is a web-based data collection tool that was custom-built for this project. It was developed based on a patented approach (Canadian patent #2,666,569; issued 2/28/2017)
Patient-level variables for our models will include baseline demographic (age, sex), comorbidity [body mass index (BMI), chronic kidney disease (dialysis-dependent vs. not), diabetes mellitus, cardiovascular disease (coronary artery disease, peripheral vascular disease, cerebrovascular disease), congestive heart failure, respiratory disease, liver disease, abdominal scarring, history of abdominal hernias], laboratory (hemoglobin, albumin), and medication variables (use of anticoagulants, antiplatelet, immunosuppressive medications).
Operator variables include operator volume, advanced training in PD catheter insertion and years of experience placing PD catheters.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients must be 18 years of age or older; have advanced chronic kidney disease; have chosen PD as their intended treatment modality; and undergone their first PD catheter placement during the study period.
排除标准
- •patients who intend to transfer to another PD program or who are scheduled to receive a transplant within 3 months of the start of PD therapy will be excluded
结局指标
主要结局
Insertion related complications
时间窗: 1 year following the start of PD therapy
Complications (exit site leak, flow restriction, pain, infection, bleeding) likely associated with the method of insertion
次要结局
未报告次要终点
研究者
Matthew Oliver
Associate Professor
Sunnybrook Health Sciences Centre