Prevention of Peritonitis in Patients With Peritoneal Dialysis - Effects of Regular Follow-up of Patients´ Theoretical Knowledge and Practical Skills With Focus on Infection Prophylaxis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 713
- 试验地点
- 2
- 主要终点
- Time to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control Group
研究概览
简要总结
BACKGROUND: Peritonitis remains a significant problem in peritoneal dialysis (PD). It is the leading cause of technique failure, and contributes to mortality. The incidence is highest during the first year of treatment. Non-compliance with the PD protocol is shown to be an important risk factor for peritonitis. Reinforcement of knowledge and ability to perform PD therefore appears to be a possible way to reduce the incidence of peritonitis. This will be studied in The PEritonitis Prevention Study (PEPS).
METHODS: The objective of this randomized, multi-centre investigation, which will include 750 new PD patients who can perform (PD) without assistance, is to evaluate if regular retraining can reduce the incidence of peritonitis, the technique-failure rate, and the hospitalisation days due to peritonitis compared with regular follow-up regimen. Patients in the intervention group will be tested by a PD-technique test and a questionnaire at regular intervals after PD-start and after every peritonitis episode with focus on infection prophylaxis. If needed, they will be retrained. The control group will be treated according to the routine of the center.
The study is ongoing in Denmark, Norway, Sweden, Finland, Estonia, Latvia, the Netherlands, and the United Kingdom (UK). The study will go on for 6 years.
详细描述
BACKGROUND See above.
AIMS The primary aim of this trial is to study if regular follow-up of PD patients with testing of their theoretical and practical knowledge (hereafter called "new type of follow-up") can reduce the time to first peritonitis episode. Secondary aims were to study if the new type of follow-up could reduce the incidence of peritonitis, the technique failure rate related to peritonitis, and the time of hospitalization related to peritonitis compared to a routine regimen. For specific aims, see "Outcome measures" below. A further aim was to study risk factors for peritonitis.
PATIENTS AND METHODS The study is a randomized, multi-centre investigation intending to enclose 750 new PD patients in Sweden, Denmark, Norway, Finland, Estonia, Latvia, the Netherlands, and the United Kingdom. Inclusion was finished on December 31, 2014. The study will go on until the last included patient has taken part of the study for one year. The study will thus be terminated on December 31, 2015.
The study includes a retraining group and a control group. The intervention in the retraining group consists of regular testing of theoretical and practical knowledge regarding PD with focus on infection prophylaxis including retraining if needed until the test goals are reached. The control group will be treated according to the routines of the center. Peritonitis is defined according to International Society for Peritoneal Dialysis (SPD) guidelines (Peritoneal Dialysis International 2005;25:107-131)
The baseline PD training will be the same at all participating centres and follow international recommendations. In addition, fluorescent alcohol and a UV lamp will be used to control the result of hand disinfection in all patients once during the initial PD training. Thereafter this method will only be used in the retraining group..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patient is able to perform PD without assistance
- •Age 18 years old or more
排除标准
- •Previous PD-treatment less than 2 years ago
- •Peritonitis before inclusion
- •Active malignancy
- •Participation in other studies during the study period which may affect outcome of the present study
研究组 & 干预措施
The retraining group
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
干预措施: Retraining (Behavioral)
Control group
Patients randomised to the control group will be treated according to the routines of the clinic.
结局指标
主要结局
Time to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control Group
时间窗: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. Time to first peritonitis was calculated for each participant.
Time (days) after the date of randomization to the date of the first peritonitis episode was calculated for each participant. The cumulative time without peritonitis using the Cox regression model from which unadjusted hazard ratios were calculated. Actuarial survival curves showing proportions of peritonitis-free participants over time in the two groups were estimated by means of the Kaplan-Meier method. Log rank follow-up was used to compare the survival curves. Patients who stopped PD treatment due to causes other than peritonitis were managed according to the intention-to-treat principle.
次要结局
- Incidence of a First Dialysis-associated Peritonitis Episode in the Control and the Retraining Group(The participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. The time in study was calculated for each participant)
- Incidence of All Peritonitis Episodes in the Control Group and the Retraining Group(The participants were followed from 1 month after PD start (time of randomization) up to 36 months after start of peritoneal dialysis, The time (days) of participation in the study was calculated for each participant.)
研究者
Susanne Ljungman
professor
Sahlgrenska University Hospital