Randomized Multicentric Clinical Trial, Efficcacy of the Treatment Application on Peritonitis in Automated Peritoneal Dialysis (APD); Comparision Between APD Versus Ambulatory Dialysis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 6
- 主要终点
- Peritonitis Resolved
研究概览
简要总结
The main infectious complication of peritoneal dialysis (PD) is bacterial peritonitis, which increases morbidity, mortality and conversion to hemodialysis.
In Mexico, 485 patients per million people undergo PD. The Mexican Institute of Social Security (IMSS) reported 55,101 patients with kidney failure, 59% on PD. Automated PD (APD) has contributed by reducing peritonitis. The treatment of peritonitis in APD is carried out by changing to continuous ambulatory peritoneal dialysis (CAPD) or by adding a CAPD/day replacement, increasing costs and delaying treatment. OBJECTIVE: To compare the efficacy of peritonitis antibiotic treatment applied in a DPA bag versus applied in a CAPD/day replacement plus APD in IMSS beneficiaries. MATERIAL AND METHODS: A non-inferiority, multicenter clinical trial was carried out with patients> 18 years of age in APD with peritonitis. Group 1 (g1) receives antibiotics in DPA bags, group 2 (g2) receives antibiotics in a CAPD / day exchange plus APD. The antibiotics applied were ceftazidime 1500 mg / day 14 days and vancomycin 20 mg / kg every 3 days, 5 doses adjusted according to culture, followed by cytology every 48 hours until clinical resolution. Considering resolved peritonitis when symptoms disappeared and white blood cells <100 cells / mm3 were obtained in cytology. The Research and Ethics Committee approved the study. Relative risk (RR), relative risk reduction (RRR) were calculated. The Chi squared test, Student's t test, non-inferiority analysis was calculated considering p <0.05 significant, SPSS 24 and Epi Info were used.
详细描述
GENERAL DESCRIPTION OF THE STUDY.
PROCEDURES:
Patients with peritonitis (clinical, cytological sample with leukocytes >100/μL, and >50% Polymorphonuclear, taken from a dialysis exchange with 2 to 4 h of stay in the cavity, gram positive or positive culture of dialysis fluid) in Automated peritoneal dialysis of the general hospitals of the Mexican Institute zone Social Security No. 1, 10 and subzone 4 in the state of Colima. Two groups each of 32 patients were forming. Both created treatment groups received antibiotic management based on a double antibiotic scheme with Vancomycin and Ceftazidime via intraperitoneal (IP), the difference was for the treatment group (group 1) the application of the antibiotic through the 6L bags in APD through the cycler machine versus for the control group (group 2) the addition of a manual exchange (CAPD) of 6 hours of stay in extra cavity during the day for the application of the antibiotic plus the
Usual APD at night, the management of peritonitis in each group was established according to the following way:
- Group 1: IP antibiotic treatment applied inside DPA bags. Applied Vancomycin-based antibiotic 20 mg/kg every 72 hours (3 days) applied to bags of DPA (50% in each bag of the total dose) in night exchange every 3 days completing 5 doses, and Ceftazidime 1500mg applied in bags of DPA (50% in each bag of the total dose) each day for 14 days.
- Group 2: IP antibiotic treatment applied to one manual exchange (CAPD) per day, with a stay of 6 hours plus usual DPA programmed at night. The dose administered was Vancomycin 20 mg/kg every 72 hours (3 days) completing 5 dose, and Ceftazidime 1500 mg/day in a manual exchange with a stay of 6 hours for 14 days plus the usual prescribed DPA at night.
- Both groups received training and reviewed the correct application of the antibiotic by the nursing staff of the peritoneal dialysis service during hospitalization or at appointments in the peritoneal dialysis program.
- The researchers and staff of the dialysis program maintained a follow-up of the cases during their stay in hospital, through home visits, phone call and check-up medical appointment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
the outcomes assessor will mask to do statistical analisis
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years in Automated Peritoneal Dialysis.
- •Patients in the Hospital General 1, 10 and sub-zone 4 of Colima.
- •Patients with diagnosis of peritonitis (abdominal pain, fever, vomiting, nausea, turbid fluid, cytologic with leukocytes >100 cells/mm3, polymorphonuclear >50%).
- •Functional catheter.
- •Signed informed consent of acceptance to participate in the study.
排除标准
- •Patients allergic to vancomicyn.
- •Patients allergic to ceftazidime.
- •Patients with Intestinal perforation.
- •Patients with abdominal cavity classified as unfit to PD.
结局指标
主要结局
Peritonitis Resolved
时间窗: 14 to 21 days
We consider the problem resolved when symptoms (nausea, vomiting, abdominal pain, fever, turbid fluid) have disappeared and negative cytology has been obtained (leukocytes \<100 cells/mm3)
次要结局
- Death of Patient(21 days)
研究者
J JESUS VENEGAS, D. Sc.
Master Degree
Universidad de Colima