Treatment of Peritonitis in Automated Peritoneal Dialysis

April 5, 2023 updated by: J JESUS VENEGAS, D. Sc., Universidad de Colima

Randomized Multicentric Clinical Trial, Efficcacy of the Treatment Application on Peritonitis in Automated Peritoneal Dialysis (APD); Comparision Between APD Versus Ambulatory Dialysis.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Colima, Mexico, 28979
        • Hgz 1 Instituto Mexicano Del Seguro Social
    • Colima
      • Manzanillo, Colima, Mexico, 28100
        • Hgz 10 Instituto Mexicano Del Seguro Social
      • Tecoman, Colima, Mexico, 28100
        • Hgsz 4 Instituto Mexicano Del Seguro Social

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Peritonitis treatment with one exchange in CAPD
This group will receive peritonitis treatment with one exchange on Continuous Ambulatory Peritoneal Dialysis per day. The initial antibiotic scheme will be with ceftazidime (1500mg/day) and vancomycin (20mg/kg every 3 days) according to current management guidelines; adjusting the management according to the result of the culture, completing the antibiotic scheme for 14 to 21 days.
Device: Peritonitis treatment with one exchange in CAPD
Antibiotic treatment of peritontiis placed in one bag of Continuos ambulatory peritoneal dialysis per 6 hours each day.
Experimental: Peritonitis treatment placed in APD
This group will receive peritonitis treatment placed in Automated Peritoneal Dialysis. The initial antibiotic scheme will be with ceftazidime (1500mg/day) and vancomycin (20mg/kg every 3 days); adjusting the management according to the result of the culture, completing the antibiotic scheme for 14 to 21 days.
Device: Peritonitis treatment placed in APD
Antibiotic treatment of peritontiis placed in bags of Automated peritoneal dialysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peritonitis resolved
Time Frame: 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)
14 to 21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sympotms resolved
Time Frame: 14-21 days
We consider the symptoms resolved if the nausea, vomiting, abdominal pain, fever, turbid fluid disappears
14-21 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative cytology
Time Frame: 21 days
When cytology shows leukocytes <100 cells/mm3
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Colima

Collaborators

Instituto Mexicano del Seguro Social

Investigators

  • Study Director: Benjamin Trujillo, DS, Universidad de Colima

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

September 1, 2019

First Submitted That Met QC Criteria

September 3, 2019

First Posted (Actual)

September 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01APDPERITONITIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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