Treatment of Peritonitis in Automated Peritoneal Dialysis
Condition: Secondary Peritonitis
MeSH terms: Peritonitis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      GENERAL DESCRIPTION OF THE STUDY.

      PROCEDURES:

      71 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. 7 patients were excluded for not meeting inclusion criteria, finally
      using a table of random numbers 66 patients were randomized, of which 2 patients did not
      complete the course. study for not complying with the treatment scheme, excluding themselves
      from the study and forming 2 groups each of 32 patients. 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.

      Patients and relatives were informed in detail about the research project companions
      mentioning the objectives, risks and benefits of this, their Authorization for inclusion in
      the study by signing an endorsed informed consent by the national ethics and research
      committee of the IMSS. Through direct interview and review of the medical record, general and
      demographic data, data on associated pathologies, comorbidities, time in management with
      peritoneal dialysis, time of APD management, number of peritoneal catheters placed, APD
      prescription, diuresis residual, dose of erythropoietin, onset of the clinical picture of
      peritonitis, as well as the characteristics of the initial frame, time elapsed from the
      beginning of the frame to the performance of cytology. Possible triggering causes of the
      symptoms of peritonitis, the peritoneal dialysis technique was verified, other probable sites
      of infection and close contact was maintained with the medical team in charge of managing the
      cases hospitalized. After the diagnosis or suspicion of the case of peritonitis, a culture of
      fluid was taken from dialysis (LD) without antibiotics, and was reviewed at 48 and 72 h and 5
      days after starting the treatment, collecting the report with corresponding antibiogram.
      Cultivation was the basis for making the decision to change the antibiotic according to the
      sensitivity and reported resistance. All patients underwent fluid cytology controls.

      of PD every 48 hours in hospitalization or by scheduled appointment to PD programs from each
      hospital. The cytological ones were obtained from a manual exchange (CAPD) with 2 to 4 hours
      of stay in the cavity without antibiotics to determine the evolution of the symptoms of
      peritonitis. Through the cytological results and the clinical characteristics, the resolution
      of the peritonitis. At the beginning and at the end of the peritonitis, biochemical studies
      were performed: complete blood count (CBC), blood chemistry (QS), serum electrolytes (Na, K,
      Cl), general urinalysis (EGO) in case of residual urine, culture of site discharge catheter
      insertion in case of presenting and culture of peritoneal dialysis fluid.

      Recorded the clinical features of peritonitis (cloudy PD fluid, abdominal pain, nause).
    

Intervention name(s): Peritonitis treatment placed in APD; Peritonitis treatment with one exchange in CAPD
Intervention type(s): Device; Device
Intervention description(s): Antibiotic treatment of peritontiis placed in bags of Automated peritoneal dialysis.; Antibiotic treatment of peritontiis placed in one bag of Continuos ambulatory peritoneal dialysis per 6 hours each day.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly through table of random numbers, and divided to form two treatment groups with 51 patients per group. One of which will be a APD and the other a CAPD. The initial antibiotic scheme will be applied to both groups continuously based on: ceftazidime (1500-2000mg/day) and vancomycin (20mg/kg every 3 days) according to current management guidelines;
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PERITONITIS; AUTOMATED PERITONEAL DIALYSIS; TREATMENT OF PERITONITIS