Clinical trial NCT04077996: Treatment of Peritonitis in Automated Peritoneal Dialysis
Official title: Randomized Multicentric Clinical Trial, Efficcacy of the Treatment Application on Peritonitis in Automated Peritoneal Dialysis (APD); Comparision Between APD Versus Ambulatory Dialysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Secondary Peritonitis
Keywords: PERITONITIS
AUTOMATED PERITONEAL DIALYSIS
TREATMENT OF PERITONITIS
Lead sponsor: Universidad de Colima
Sponsor class: OTHER
Collaborators: name: Instituto Mexicano del Seguro Social
First posted: 2019-09-04
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly through table of random numbers, and divided to form two treatment groups with 32 patients per group. One of which will be a APD and the other a CAPD + APD. 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;
Primary purpose: TREATMENT

Brief 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:

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.

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).

Eligibility criteria: Inclusion Criteria:

* \> 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.

Exclusion Criteria:

* Patients allergic to vancomicyn.
* Patients allergic to ceftazidime.
* Patients with Intestinal perforation.
* Patients with abdominal cavity classified as unfit to PD.

Primary outcomes:
measure: Peritonitis Resolved
timeFrame: 14 to 21 days
Secondary outcomes:
measure: Death of Patient
timeFrame: 21 days
Other outcomes:
Locations:
city: Manzanillo
country: Mexico
facility: Hgz 10 Instituto Mexicano Del Seguro Social
state: Colima
city: Tecoman
country: Mexico
facility: Hgsz 4 Instituto Mexicano Del Seguro Social
state: Colima
city: Colima
country: Mexico
facility: Hgz 1 Instituto Mexicano Del Seguro Social
Study officials:
affiliation: Universidad de Colima
name: Benjamin Trujillo, DS
role: STUDY_DIRECTOR
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