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Treatment of Peritonitis in Automated Peritoneal Dialysis

Primary Purpose

Secondary Peritonitis

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Peritonitis treatment placed in APD
Peritonitis treatment with one exchange in CAPD
Sponsored by
Universidad de Colima
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Peritonitis focused on measuring PERITONITIS, AUTOMATED PERITONEAL DIALYSIS, TREATMENT OF PERITONITIS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hgz 10 Instituto Mexicano Del Seguro Social
  • Hgsz 4 Instituto Mexicano Del Seguro Social
  • Hgz 1 Instituto Mexicano Del Seguro Social

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Peritonitis treatment with one exchange in CAPD

Peritonitis treatment placed in APD

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Peritonitis resolved
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)

Secondary Outcome Measures

sympotms resolved
We consider the symptoms resolved if the nausea, vomiting, abdominal pain, fever, turbid fluid disappears

Full Information

First Posted
September 1, 2019
Last Updated
April 5, 2023
Sponsor
Universidad de Colima
Collaborators
Instituto Mexicano del Seguro Social
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1. Study Identification

Unique Protocol Identification Number
NCT04077996
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Colima
Collaborators
Instituto Mexicano del Seguro Social

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Peritonitis
Keywords
PERITONITIS, AUTOMATED PERITONEAL DIALYSIS, TREATMENT OF PERITONITIS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
the outcomes assessor will mask to do statistical analisis
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peritonitis treatment with one exchange in CAPD
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Peritonitis treatment placed in APD
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Peritonitis treatment placed in APD
Intervention Description
Antibiotic treatment of peritontiis placed in bags of Automated peritoneal dialysis.
Intervention Type
Device
Intervention Name(s)
Peritonitis treatment with one exchange in CAPD
Intervention Description
Antibiotic treatment of peritontiis placed in one bag of Continuos ambulatory peritoneal dialysis per 6 hours each day.
Primary Outcome Measure Information:
Title
Peritonitis resolved
Description
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)
Time Frame
14 to 21 days
Secondary Outcome Measure Information:
Title
sympotms resolved
Description
We consider the symptoms resolved if the nausea, vomiting, abdominal pain, fever, turbid fluid disappears
Time Frame
14-21 days
Other Pre-specified Outcome Measures:
Title
Negative cytology
Description
When cytology shows leukocytes <100 cells/mm3
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Trujillo, DS
Organizational Affiliation
Universidad de Colima
Official's Role
Study Director
Facility Information:
Facility Name
Hgz 10 Instituto Mexicano Del Seguro Social
City
Manzanillo
State/Province
Colima
ZIP/Postal Code
28100
Country
Mexico
Facility Name
Hgsz 4 Instituto Mexicano Del Seguro Social
City
Tecoman
State/Province
Colima
ZIP/Postal Code
28100
Country
Mexico
Facility Name
Hgz 1 Instituto Mexicano Del Seguro Social
City
Colima
ZIP/Postal Code
28979
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28153192
Citation
Li PK, Kwong VW. Current Challenges and Opportunities in PD. Semin Nephrol. 2017 Jan;37(1):2-9. doi: 10.1016/j.semnephrol.2016.10.002.
Results Reference
background
PubMed Identifier
27282851
Citation
Li PK, Szeto CC, Piraino B, de Arteaga J, Fan S, Figueiredo AE, Fish DN, Goffin E, Kim YL, Salzer W, Struijk DG, Teitelbaum I, Johnson DW. ISPD Peritonitis Recommendations: 2016 Update on Prevention and Treatment. Perit Dial Int. 2016 Sep 10;36(5):481-508. doi: 10.3747/pdi.2016.00078. Epub 2016 Jun 9. No abstract available. Erratum In: Perit Dial Int. 2018 Jul-Aug;38(4):313.
Results Reference
background
PubMed Identifier
20558813
Citation
Ruger W, van Ittersum FJ, Comazzetto LF, Hoeks SE, ter Wee PM. Similar peritonitis outcome in CAPD and APD patients with dialysis modality continuation during peritonitis. Perit Dial Int. 2011 Jan-Feb;31(1):39-47. doi: 10.3747/pdi.2009.00235. Epub 2010 Jun 17.
Results Reference
result
PubMed Identifier
12227392
Citation
Fielding RE, Clemenger M, Goldberg L, Brown EA. Treatment and outcome of peritonitis in automated peritoneal dialysis, using a once-daily cefazolin-based regimen. Perit Dial Int. 2002 May-Jun;22(3):345-9.
Results Reference
result
PubMed Identifier
24626434
Citation
Lan PG, Johnson DW, McDonald SP, Boudville N, Borlace M, Badve SV, Sud K, Clayton PA. The association between peritoneal dialysis modality and peritonitis. Clin J Am Soc Nephrol. 2014 Jun 6;9(6):1091-7. doi: 10.2215/CJN.09730913. Epub 2014 Mar 13.
Results Reference
result
PubMed Identifier
24385333
Citation
de Moraes TP, Olandoski M, Caramori JC, Martin LC, Fernandes N, Divino-Filho JC, Pecoits-Filho R, Barretti P. Novel predictors of peritonitis-related outcomes in the BRAZPD cohort. Perit Dial Int. 2014 Mar-Apr;34(2):179-87. doi: 10.3747/pdi.2012.00333. Epub 2014 Jan 2.
Results Reference
result
PubMed Identifier
27435043
Citation
El-Reshaid W, Al-Disawy H, Nassef H, Alhelaly U. Comparison of peritonitis rates and patient survival in automated and continuous ambulatory peritoneal dialysis: a 10-year single center experience. Ren Fail. 2016 Sep;38(8):1187-92. doi: 10.1080/0886022X.2016.1209025. Epub 2016 Jul 19.
Results Reference
result
PubMed Identifier
18379553
Citation
Sanchez AR, Madonia C, Rascon-Pacheco RA. Improved patient/technique survival and peritonitis rates in patients treated with automated peritoneal dialysis when compared to continuous ambulatory peritoneal dialysis in a Mexican PD center. Kidney Int Suppl. 2008 Apr;(108):S76-80. doi: 10.1038/sj.ki.5002606.
Results Reference
result
PubMed Identifier
27738089
Citation
Peerapornratana S, Chariyavilaskul P, Kanjanabuch T, Praditpornsilpa K, Eiam-Ong S, Katavetin P. Short-Dwell Cycling Intraperitoneal Cefazolin Plus Ceftazidime in Peritoneal Dialysis Patients. Perit Dial Int. 2017 Mar-Apr;37(2):218-224. doi: 10.3747/pdi.2015.00300. Epub 2016 Oct 13.
Results Reference
result
PubMed Identifier
27147292
Citation
Deslandes G, Gregoire M, Bouquie R, Le Marec A, Allard S, Dailly E, Pineau A, Allain-Launay E, Jolliet P, Roussey G, Navas D. Stability and Compatibility of Antibiotics in Peritoneal Dialysis Solutions Applied to Automated Peritoneal Dialysis in The Pediatric Population. Perit Dial Int. 2016 11-12;36(6):676-679. doi: 10.3747/pdi.2015.00018. Epub 2016 May 4.
Results Reference
result
PubMed Identifier
21242698
Citation
Odudu A, Wilkie M. Controversies in the management of infective complications of peritoneal dialysis. Nephron Clin Pract. 2011;118(3):c301-8. doi: 10.1159/000322227. Epub 2011 Jan 14.
Results Reference
result

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Treatment of Peritonitis in Automated Peritoneal Dialysis

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