Treatment of Peritonitis in Automated Peritoneal Dialysis
Study Details
Study Description
Brief Summary
INTRODUCTION: Secondary bacterial peritonitis is the main infectious complication associated with peritoneal dialysis (PD), is associated with increased morbidity and mortality. The peritonitis is the first cause of conversion to hemodialysis. Automated peritoneal dialysis (APD) can perform a certain number of cycles over a period of time. The APD is growing and has decreased the cases of peritonitis compared with continuous ambulatory peritoneal dialysis (CAPD). Actually, the method of antibiotic treatment of peritonitis in APD is changing to CAPD modality; or adding an additional replacement during the day. The treatment with antibiotics in APD is unknown.
OBJECTIVE: To compare the efficacy of antibiotic treatment aplication of peritonitis in APD using standar technique vs aplication in APD in patients of IMSS.
MATERIAL AND METHODS: One hundred and two patient through a random, simple blind, comparative clinical trial, investigators will be included patients >18 years in APD in 3 hospitals of Colima, with diagnosis of peritonitis, functional catheter. One of which will be peritonitis treatment with APD and the other with one exchange on CAPD per day. The initial antibiotic scheme will be applied to both groups continuously based on: 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. The clinical progress will be monitored until there is resolution. Investigators consider the problem resolved when symptoms have disappeared and negative cytology has been obtained. Investigators will collect demographic data, comorbidity, time in PD and APD, causes of peritonitis; verify PD technique, residual uresis, other sites of infection and previous peritonitis.
STATISTICAL ANALYSIS: Includes descriptive of clinical characteristics of patients. Investigators will use relative risk, reduction of relative risk, and number necessary to treat. Qualitative variables will be analized by: Chi square test, Fisher's exact test, as appropriate. To compare quantitative variables the U Mann Whitney or t Student can be used. Logistic regression will be use to perform multivariable analysis. SPSS 24 will be used. Investigators consider significancy p<0.05.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
INTRODUCTION: Secondary bacterial peritonitis, the main infectious complication associated with peritoneal dialysis (PD), is associated with increased morbidity and mortality. Diagnosis of peritonitis include signs and symtoms: nausea, vomiting hyporexia, diarrea, abdominal pain, fever, cloudy fluid, altered cytology and others. Mexico reported end-stage renal disease in 866 patients per million population (pmp) and 485 pmp in treatment with PD. The Instituto Mexicano del Seguro Social (IMSS) report end-stage renal disease in 55,101 patients and 59% in DP treatment. The peritonitis is the first cause of morbidity in patients with DP and main cause of conversion to hemodialysis. In our country, peritonitis has been reported with a rate of 1.2 episodes/year per patient, superior to international recommendations. Automated peritoneal dialysis (APD), using the cycler connected to the patient via tubing and programed to perform a certain number of cycles over a period of time. The use of APD is growing in all the world and has decreased the cases of peritonitis compared with continuous ambulatory peritoneal dialysis (CAPD). CAPD has known as manual dialysis, usually need 3 exchange in day and 1 exchange in the night with duration time of 5 to 6 hours. The antibiotic treatment in peritonitis should be with first generation cephalosporin or vancomicin or third generation cephalosporins or aminoglycoside. Actually, the method of antibiotic treatment of peritonitis in APD is changing to CAPD modality; or adding an additional replacement during the day. But this form of treatment increases the cost to patient and institutions. It is not practial, because the patient is not trained to change to CAPD and resources to CAPD are not inmediately available. However, the treatment with antibiotics in APD is unknown. Actual recommendation of international guidelines is to develop more clinical trials to increase the evindece on this topic. There are not enough clinical studies to support or to rule out it´s effectiveness.
OBJECTIVE: To compare the efficacy of antibiotic treatment aplication of peritonitis in APD using standar technique vs aplication in APD in patients of IMSS.
HIPOTHESIS: The efficacy of antibiotic treatment of peritonitis in APD is superior treatment than in CAPD technique, with patients who are insured by IMSS.
MATERIAL AND METHODS: One hundred and two patient samples calculated to estimate two proportions with a confidence level of 0.05 and 80% power. Through a random, simple blind, comparative clinical trial, aproved to national IMSS commite will be included patients > 18 years in APD at the Hospital General 1, 10 and sub-zone 4 of Colima, with diagnosis of peritonitis (abdominal pain, turbid fluid, cytologic with leukocytes >100 cells/mm3, polymorphonuclear >50%), functional catheter and signed informed consent of acceptance to participate in the study will be included. Patients allergic to vancomicyn and ceftazidime will be not included. Intestinal perforation, abdominal cavity classified as unfit to PD, adverse effects of antibiotic and patients who decide to leave the study will be elimination criteria. Patients will be selected through a table of random numbers, and divided to form two treatment groups with 51 patients. One of which will be peritonitis treatment with APD and the other with one exchange on CAPD per day. The initial antibiotic scheme will be applied to both groups continuously based on: 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. Cytological analysis of dialysis fluid will be performed each two days. The clinical progress will be monitored until there is resolution, either in the hospital or in the patient´s home. We consider the problem resolved when symptoms have disappeared and negative cytology has been obtained (leukocytes <100 cells/mm3). Patients will be excluded if they present adverse effects to antibiotics, intestinal perforation, abdominal cavity unfit to PD, fungal peritonitis, patients who decide to leave the study. We will collect demographic data, comorbidity, time in PD and APD, causes of peritonitis; verify PD technique, residual uresis, other sites of infection and previous peritonitis. Dependent variable is peritonitis, and indepentent variable is antibiotic treatment in PD and intervening variables are type 2 Diabetes, insertion site infection, tunelitis, previous peritonitis, time in PD, error in technique of PD.
STATISTICAL ANALYSIS: Includes descriptive and statistic inference of clinical characteristics of patients. The presentation of data hovers through a descriptive statistic (mean or median, standard deviation or interquartile range depending on the distribution of the data through Kolmogorov-Smirnov). To know the effect of the treatment we will use methods of relative risk, reduction of relative risk, and number necessary to treat. The observation of qualitative variables will be determined by: Chi square test, Fisher's exact test, as appropriate. To compare quantitative variables between groups, the U Mann Whitney or t Student can be used. Logistic regression will be use to perform multivariable analysis. The statistical package SPSS 24 will be used. We will be considering significancy if p<0.05. The resources used are contributed by the researchers and the IMSS. The estimated time to develop the study is 12 months.
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Peritonitis resolved [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)
Secondary Outcome Measures
- sympotms resolved [14-21 days]
We consider the symptoms resolved if the nausea, vomiting, abdominal pain, fever, turbid fluid disappears
Other Outcome Measures
- Negative cytology [21 days]
When cytology shows leukocytes <100 cells/mm3
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years in Automated Peritoneal Dialysis.
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Patients in the Hospital General 1, 10 and sub-zone 4 of Colima.
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Patients with diagnosis of peritonitis (abdominal pain, fever, vomiting, nausea, turbid fluid, cytologic with leukocytes >100 cells/mm3, polymorphonuclear >50%).
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Functional catheter.
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Signed informed consent of acceptance to participate in the study.
Exclusion Criteria:
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Patients allergic to vancomicyn.
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Patients allergic to ceftazidime.
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Patients with Intestinal perforation.
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Patients with abdominal cavity classified as unfit to PD.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hgz 10 Instituto Mexicano Del Seguro Social | Manzanillo | Colima | Mexico | 28100 |
| 2 | Hgsz 4 Instituto Mexicano Del Seguro Social | Tecoman | Colima | Mexico | 28100 |
| 3 | Hgz 1 Instituto Mexicano Del Seguro Social | Colima | Mexico | 28979 |
Sponsors and Collaborators
- Universidad de Colima
- Instituto Mexicano del Seguro Social
Investigators
- Study Director: Benjamin Trujillo, DS, Universidad de Colima
Study Documents (Full-Text)
None provided.More Information
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. Review.
- 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. Review. Erratum in: Perit Dial Int. 2018 Jul-Aug;38(4):313.
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