Secondary PeritonitisNCT04077996
Treatment of Peritonitis in Automated Peritoneal Dialysis
A study testing Peritonitis treatment placed in APD and Peritonitis treatment with one exchange in CAPD in people with Secondary Peritonitis, run by Universidad de Colima at 3 sites in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Secondary Peritonitis
- What is being tested?
- Peritonitis treatment placed in APD and Peritonitis treatment with one exchange in CAPD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesMexico
- Study dates
- 1 Jul 2019to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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.
Who cannot join
- Patients allergic to vancomicyn.
- Patients allergic to ceftazidime.
- Patients with Intestinal perforation.
- Patients with abdominal cavity classified as unfit to PD.
Trial locations and contacts
3 sites in 1 country.
Mexico3 sites
Hgz 1 Instituto Mexicano Del Seguro Social
Colima, 28979
Hgz 10 Instituto Mexicano Del Seguro Social
Manzanillo, Colima, 28100
Hgsz 4 Instituto Mexicano Del Seguro Social
Tecomán, Colima, 28100
About this study
Official title: 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.
Read the 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).
- Conditions
- Secondary Peritonitis
- Being tested
- Peritonitis treatment placed in APD, Peritonitis treatment with one exchange in CAPD
- Keywords
- PERITONITIS, AUTOMATED PERITONEAL DIALYSIS, TREATMENT OF PERITONITIS
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritonitis treatment placed in APDDevice
Antibiotic treatment of peritontiis placed in bags of Automated peritoneal dialysis.
Peritonitis treatment with one exchange in CAPDDevice
Antibiotic treatment of peritontiis placed in one bag of Continuos ambulatory peritoneal dialysis per 6 hours each day.
| Study group | Role | What they receive |
|---|---|---|
| Peritonitis treatment with one exchange in CAPD | Active comparator | 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. Receives: Device: Peritonitis treatment with one exchange in CAPD |
| Peritonitis treatment placed in APD | Experimental | 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. Receives: Device: Peritonitis treatment placed in APD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 14 to 21 days
Secondary outcomes (1)
Death of Patient
Total number and percentage of patients
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Jul 2019
- Primary completion30 Jul 2021
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Secondary PeritonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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;
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Colima
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Mexicano del Seguro Social
- Responsible party
- Principal investigator, J JESUS VENEGAS, D. Sc., Universidad de Colima
- Investigators
- Benjamin Trujillo, DS, Study director, Universidad de Colima
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077996
- Sponsor's protocol ID
- 01APDPERITONITIS
- Status last verified
- Mar 2025
- First submitted
- 1 Sep 2019
- Last updated
- 26 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28153192Li 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.
PubMed 27282851Ruger 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.
PubMed 20558813Fielding 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.
PubMed 12227392Lan 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.
PubMed 24626434de 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.
PubMed 24385333El-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.
PubMed 27435043Sanchez 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.
PubMed 18379553Peerapornratana 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.
PubMed 27738089Deslandes 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.
PubMed 27147292Odudu 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.
PubMed 21242698Venegas-Ramirez J, Trujillo-Hernandez B, Castillon-Flores CC, Landin-Herrera FJ, Herrera-Oliva E, Calvo-Soto P, Tapia-Vargas R, Figueroa-Gutierrez A, Rios-Bracamontes EF, Espinoza-Mejia KE, Jimenez-Vieyra IA, Bermudez-Aceves LA, Avila-Flores BJ, Murillo-Zamora E. Simplifying Antibiotic Management of Peritonitis in APD: Evidence from a Non-Inferiority Randomized Trial. Antibiotics (Basel). 2025 Jul 24;14(8):747. doi: 10.3390/antibiotics14080747.
PubMed 40867942
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicentric Clinical Trial, Efficcacy of the Treatment Application on Peritonitis in Automated Peritoneal Dialysis (APD); Comparision Between APD Versus Ambulatory Dialysis.
- ClinicalTrials.gov ID
- NCT04077996
- Acronym / sponsor ID
- 01APDPERITONITIS
- Conditions
- Secondary Peritonitis
- Keywords
- PERITONITIS, AUTOMATED PERITONEAL DIALYSIS, TREATMENT OF PERITONITIS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universidad de ColimaUniversity, hospital or other
- Collaborators
- Instituto Mexicano del Seguro Social
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Posted 26 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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;
| Arm | Type | Receives |
|---|---|---|
| Peritonitis treatment with one exchange in CAPD | Active comparator | Device: Peritonitis treatment with one exchange in CAPDThis 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. |
| Peritonitis treatment placed in APD | Experimental | Device: Peritonitis treatment placed in APDThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 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.
Key exclusion criteria (4 listed)
- Patients allergic to vancomicyn.
- Patients allergic to ceftazidime.
- Patients with Intestinal perforation.
- Patients with abdominal cavity classified as unfit to PD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peritonitis treatment placed in APDAntibiotic treatment of peritontiis placed in bags of Automated peritoneal dialysis. | Device | Peritonitis treatment placed in APD |
| Peritonitis treatment with one exchange in CAPDAntibiotic treatment of peritontiis placed in one bag of Continuos ambulatory peritoneal dialysis per 6 hours each day. | Device | Peritonitis treatment with one exchange in CAPD |
Primary outcome
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)
1 secondary outcome
Death of Patient
Time frame: 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28153192Li 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.
- Background: PubMed 27282851Li 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.
- Background: PubMed 20558813Ruger 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.
- Background: PubMed 12227392Fielding 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.
- Background: PubMed 24626434Lan 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.
- Background: PubMed 24385333de 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.
- Background: PubMed 27435043El-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.
- Background: PubMed 18379553Sanchez 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.
- Background: PubMed 27738089Peerapornratana 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.
- Background: PubMed 27147292Deslandes 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.
- Background: PubMed 21242698Odudu 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.
- Derived from this study: PubMed 40867942Venegas-Ramirez J, Trujillo-Hernandez B, Castillon-Flores CC, Landin-Herrera FJ, Herrera-Oliva E, Calvo-Soto P, Tapia-Vargas R, Figueroa-Gutierrez A, Rios-Bracamontes EF, Espinoza-Mejia KE, Jimenez-Vieyra IA, Bermudez-Aceves LA, Avila-Flores BJ, Murillo-Zamora E. Simplifying Antibiotic Management of Peritonitis in APD: Evidence from a Non-Inferiority Randomized Trial. Antibiotics (Basel). 2025 Jul 24;14(8):747. doi: 10.3390/antibiotics14080747.
- Individual participant dataSharing planned: No
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Not yet recruitingPhase 4
Low-dose Norepinephrine Infusion for Prevention of Post-induction Hypotension in Emergency Surgery for Peritonitis
Secondary Peritonitis, Post-induction Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Trujillo, DS study director
Universidad de Colima
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peritonitis treatment placed in APD and Peritonitis treatment with one exchange in CAPD in people with Secondary Peritonitis, run by Universidad de Colima at 3 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritonitis Resolved (time frame: 14 to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04077996, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.