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| Name | Class |
|---|---|
| Instituto Mexicano del Seguro Social | OTHER_GOV |
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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.
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peritonitis treatment placed in APD | Device | Antibiotic treatment of peritontiis placed in bags of Automated peritoneal dialysis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 14 to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Death of Patient | Total number and percentage of patients | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Trujillo, DS | Universidad de Colima | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hgz 10 Instituto Mexicano Del Seguro Social | Manzanillo | Colima | 28100 | Mexico | ||
| Hgsz 4 Instituto Mexicano Del Seguro Social |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28153192 | Background | 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. | |
| 27282851 | Background | 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. |
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71 patients were diagnosed with peritonitis. 7 patients were excluded because, 5 patients did not meet criteria and 2 voluntary abandonment
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| ID | Title | Description |
|---|---|---|
| FG000 | Peritonitis Treatment With One Exchange in CAPD | 32 patients in 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. 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. |
| FG001 | Peritonitis Treatment Placed in APD | 32 patients in 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. Peritonitis treatment placed in APD: Antibiotic treatment of peritontiis placed in bags of Automated peritoneal dialysis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Peritonitis Treatment With One Exchange in CAPD | 32 patients in this group will receive peritonitis treatment with one exchange on Continuous Ambulatory Peritoneal Dialysis per day. The 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 with one exchange in CAPD: Antibiotic treatment of peritontiis placed in one bag of Continuos ambulatory peritoneal dialysis per 6 hours each day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Lost to follow-up two patients in the intervention group |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | non-inferiority and the intent-to-treat | Posted | Number | participants | 14 to 21 days |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Peritonitis Treatment With One Exchange in CAPD | 32 patients in 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jesus Venegas-Ramírez | Instituto Mexicano del Seguro Social | 3143058373 | nefrojesusvr@gmail.com, jesus.venegas@imss.gob.mx |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2022 | Aug 14, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010538 | Peritonitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D010531 | Peritoneal Dialysis, Continuous Ambulatory |
| ID | Term |
|---|---|
| D000553 | Ambulatory Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D010530 | Peritoneal Dialysis |
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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;
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the outcomes assessor will mask to do statistical analisis
| Peritonitis treatment with one exchange in CAPD | Device | Antibiotic treatment of peritontiis placed in one bag of Continuos ambulatory peritoneal dialysis per 6 hours each day. |
|
| Tecomán |
| Colima |
| 28100 |
| Mexico |
| Hgz 1 Instituto Mexicano Del Seguro Social | Colima | 28979 | Mexico |
| 20558813 | Background | 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. |
| 12227392 | Background | 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. |
| 24626434 | Background | 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. |
| 24385333 | Background | 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. |
| 27435043 | Background | 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. |
| 18379553 | Background | 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. |
| 27738089 | Background | 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. |
| 27147292 | Background | 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. |
| 21242698 | Background | 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. |
| 40867942 | Derived | Venegas-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. |
| BG001 | Peritonitis Treatment Placed in APD | 32 patiets in this group will receive peritonitis treatment placed in Automated Peritoneal Dialysis, The 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. Peritonitis treatment placed in APD: Antibiotic treatment of peritontiis placed in bags of Automated peritoneal dialysis. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| APD modality | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| APD per day, duration (hours) | Mean | Standard Deviation | Hours |
|
| Exchanges per day (number) | Mean | Standard Deviation | Exchanges per day (number) |
|
| Tobacco use (yes) | Count of Participants | Participants |
|
| Alcohol consumption (yes) | Count of Participants | Participants |
|
| Type 2 diabetes mellitus (yes) | Count of Participants | Participants |
|
| Arterial hypertension (yes) | Count of Participants | Participants |
|
| Hypertriglyceridemia (yes | Count of Participants | Participants |
|
| Hypercholesterolemia (yes | Count of Participants | Participants |
|
| Hyperuricemia (yes) | Count of Participants | Participants |
|
| Anemia (yes) | Count of Participants | Participants |
|
| Previous peritonitis episode (yes) | Count of Participants | Participants |
|
|
|
|
| Secondary | Death of Patient | Total number and percentage of patients | Posted | Count of Participants | Participants | 21 days |
|
|
|
|
| 2 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Peritonitis Treatment Placed in APD | 32 patients in 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. Peritonitis treatment placed in APD: Antibiotic treatment of peritontiis placed in bags of Automated peritoneal dialysis. | 2 | 32 | 0 | 32 | 0 | 32 |
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| D006435 |
| Renal Dialysis |
| D017582 | Renal Replacement Therapy |
| D016060 | Sorption Detoxification |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |