Peritoneal Dialysis as an Option of Unplanned Initiation of Chronic Dialysis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Comparasion of patients survival between unplanned PD vs. unplanned HD
研究概览
简要总结
Peritoneal dialysis (PD) has become a well-established complementary alternative to haemodialysis (HD) as first-line renal replacement modality. At department of Botucatu Medical School, more than 60% of the chronic kidney disease (CKD) stage 5 patients are started urgently on chronic dialysis due to late referral or unexpected deterioration of residual renal function. These patients, although suitable for PD, were previously started on HD using central venous catheter. Since July 2014 patients have been offered urgent start on chronic PD right after PD-catheter insertion by percutaneous surgery, using Seldinger technique. The main objective is to compare technique and patients survival on unplanned PD vs. unplanned HD in the first 180 days. Methodology: Quasi experimental study which will describe how acute PD will initiated using high volume PD until metabolic and fluid control right after (<48 h) PD catheter placement standard prescription for a 12 h overnight automatic PD until hospital discharge and intermittent PD at dialysis unit family training.
详细描述
- Background:
Chronic Kidney Disease (CKD) is a matter of global public health. Data from United States of America (USA) has shown a steady increase in the number of patients on renal replacement therapy (RRT). The census of the Brazilian Society of Nephrology (SBN) showed 65,121 patients on dialysis program in 2005, while in 2011 there were 91,314 and in 2013, there were more than 100,000 patients on dialysis in Brazil.
Among the methods of dialysis, nephrologists have two options: the peritoneal dialysis (PD) and hemodialysis (HD), which is the most commonly used method in the world. Although, historically, PD was widely used in nephrology, for not clear reasons it has been underutilized in last years, especially in incident patients on RRT. In Brazil, data from 2013 showed that 90.6% of chronic patients underwent HD and only 9.4% were treated by PD.
Several studies have compared the differences between the two types of dialysis - PD vs. HD - in incident patients on RRT. There is no evidence of the superiority of one method over the other in regards to general mortality within the first two years of therapy.
Recently, some authors have pointed out the impact of the vascular access used in the mortality of incident patients in HD. These studies found that central venous catheters (CVC) use is associated with reduced survival, especially in the first 90 days of RRT. Furthermore, there is a greater risk of bacteremia, sepsis and hospitalizations in patients using CVC when compared to patients using arteriovenous fistulas (AVF) or graft or PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Inclusion criteria are CKD patients stage 5 (creatinine clearance < 15 ml/min) requiring dialysis treatment immediately.
排除标准
- •Presence of recent abdominal surgery (less than 30 days)
- •Multiple previous abdominal surgery (more than two)
- •Severe respiratory insufficiency (FiO2> 70%)
- •Abdominal infections
- •Severe hyperkalemia with changes characteristic in EKG
- •Acute pulmonary edema.
研究组 & 干预措施
HD treatment
Patients with absolute contraindication to the PD method - presence of recent abdominal surgery (less than 30 days); multiple previous abdominal surgery (more than two); presence of fibrosis or peritoneal adhesions; fungal peritonitis; severe respiratory insufficiency (FiO2> 70%); abdominal infections; severe hyperkalemia with changes characteristic in EKG; and acute pulmonary edema - will be treated with HD.
干预措施: HD treatment (Other)
PD treatment
Patients stage 5 (creatinine clearance < 15 ml/min) requiring dialysis treatment immediately without absolute contraindication to the PD method will receive unplanned PD treatment. High volume PD (HVPD) will be used during the first 7 days of PD in order to achieve metabolic and fluid control. The procedure for acute PD has been published recently by our team . At this point, patients will be discharged from hospital and they will be treated by intermitent PD at the dialysis unit of the University Hospital.until their family be trained and home be prepared for the implementation of technique.
干预措施: PD treatment (Other)
结局指标
主要结局
Comparasion of patients survival between unplanned PD vs. unplanned HD
时间窗: 180 days
The main objective of this study is to compare patients survival on unplanned PD vs. unplanned HD in the first 180 days of therapy
次要结局
- Comparasion of hospitalization between unplanned PD vs. unplanned HD(180 days)
- Comparasion of mechanical complications (%) between unplanned PD vs. unplanned HD(180 days)
- Comparasion of infectious complications (%) between unplanned PD vs. unplanned HD(180 days)
研究者
Dayana Bitencourt Dias
Medical nephrologist
Universidade Estadual Paulista Júlio de Mesquita Filho