Educational Intervention Aimed At Reducing Infectious Complications Related to Peritoneal Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Rate of peritonitis
研究概览
简要总结
Peritonitis is a common and serious complication of peritoneal dialysis (PD) and is one of the main causes of peritoneal dialysis technique failure and long-term hemodialysis conversion.
详细描述
Peritoneal infections (PI) have been a very relevant representative of peritoneal dialysis (PD) for decades. PI is a very serious complication of PD and is a source of concern because of its high incidence. Each episode carries clinical consequences for the patient, increases in treatment costs, hospital admissions, technical failures and risk of death, especially in the 30 days following an episode.
The risk of peritonitis depends on non-modifiable factors (such as age, sex, diabetes) and modifiable factors (such as anti-infective prophylaxis, catheter care, and training).
It is important to accurately analyze the effect of modifiable factors, as they are the most relevant in reducing the rate of peritonitis.
Patient education is very important and can affect the success of the technique and clinical results. Therapeutic education has been considered a key factor in PD outcomes.
The PD nurse is responsible for training the patient and/or caregiver to be self-sufficient and autonomous in care, reinforce and highlight the importance of adherence to treatment, and promote safe actions to prevent technique-related infections when this one is made at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients >18 years of age
- •Medically stable
- •Who can perform dialysis themselves or with the help of a caregiver willing to participate in the study and sign the informed consent will be included
排除标准
- •Patients with psychiatric, psychological disorders and social (language barrier included)
- •Who do not have a formal/informal caregiver
- •Those who due to medical needs cannot continue with the standard schedule, pregnant women, participants who suffered peritonitis before receiving the educational intervention
结局指标
主要结局
Rate of peritonitis
时间窗: 1 year after educational intervention.
It is calculated as the number of episodes of peritonitis per patient and year at risk.
次要结局
- Residual renal function(Day 1 of peritoneal technique training.)
- Serum calcium(First month of the start of the technique at home.)
- Gender(Day 1 of peritoneal technique training.)
- Hemoglobin(First month of the start of the technique at home.)
- Language barrier(Day 1 of peritoneal technique training.)
- Assessment of quality of life with the questionnaire EuroQol-5D (EQ-5D)(Day 1 of peritoneal technique training.)
- Cognitive impairment -PFEIFFER Test(Day 1 of peritoneal technique training.)
- The origin before arriving at peritoneal dialysis(Day 1 of peritoneal technique training.)
- Educational level(Day 1 of peritoneal technique training.)
- Relapse(Follow-up during the first year after educational intervention.)
- Height(Day 1 of peritoneal technique training.)
- Diabetes(Day 1 of peritoneal technique training.)
- Cerebrovascular disease(Day 1 of peritoneal technique training.)
- Barthel index(Day 1 of peritoneal technique training.)
- Lawton and Brody scale(Day 1 of peritoneal technique training.)
- Age(Day 1 of peritoneal technique training.)
- Marital status(Day 1 of peritoneal technique training.)
- Weight(Day 1 of peritoneal technique training.)
- Body Mass Index (BMI)(Day 1 of peritoneal technique training.)
- Cardiovascular disease(Day 1 of peritoneal technique training.)
- Cancer(Day 1 of peritoneal technique training.)
- The primary cause of kidney disease(Day 1 of peritoneal technique training.)
- Caregiver disposition(Day 1 of peritoneal technique training.)
- Hypertension(Day 1 of peritoneal technique training.)
- Type of peritoneal catheter(Day 1 of peritoneal technique training.)
- Drinking water supply(Day 1 of peritoneal technique training.)
- Fragility detection - Q-Scale FRAIL(Day 1 of peritoneal technique training.)
- Serum phosphorus(First month of the start of the technique at home.)
- Peritonitis(Follow-up during the first year after educational intervention.)
- Time to first peritonitis(Follow-up during the first year after educational intervention.)
- Antibiotic administered(Follow-up during the first year after educational intervention.)
- Serum potassium(First month of the start of the technique at home.)
- Serum sodium(First month of the start of the technique at home.)
- Serum bicarbonate(First month of the start of the technique at home.)
- Blood urea nitrogen(First month of the start of the technique at home.)
- Reinfection(Follow-up during the first year after educational intervention.)
- Complicated peritonitis(Follow-up during the first year after educational intervention.)
- Serum albumin(First month of the start of the technique at home.)
- Orifice infection(Follow-up during the first year after educational intervention.)
- Peritoneal orifice tunnelitis(Follow-up during the first year after educational intervention.)
- Type of peritoneal infection(Follow-up during the first year after educational intervention.)
- Serum creatinine(First month of the start of the technique at home.)
- Result of peritoneal fluid culture(Follow-up during the first year after educational intervention.)
研究者
Elena Fernandez Labadia
PhD student
Universitat de Lleida