Randomized Multicentric Clinical Trial, Efficcacy of the Treatment Application on Peritonitis in Automated Peritoneal Dialysis (APD); Comparision Between APD Versus Ambulatory Dialysis.
Phase: NA
Conditions: Secondary Peritonitis
Sponsor: Universidad de Colima

 
 
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NCT04077996 
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Abstract: The objective of this study was to compare the effectiveness of allocated 
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antibiotic treatment to peritonitis in automated peritoneal dialysis (APD) bags without 
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conversion to continuous ambulatory peritoneal dialysis (CAPD), named intervention 
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group or combined APD without antibiotic plus a CAPD to allocate antibiotic for 
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managing peritonitis named control group. We conducted a multicentre non-inferiority 
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randomized, single-blind, clinical trial. Patients with peritonitis were randomly assigned 
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to receive antibiotics (Ceftazidime and Vancomycin) through either APD bags in the 
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night or a CAPD bag in the afternoon. The primary binary outcome was the complete 
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resolution of peritonitis. Data from 64 patients (32 in each group) revealed similar 
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demographic and clinical features. After 15 days, peritonitis resolved in 90.6% of the 
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intervention group and 81.3% of the control group, with no statistically significant 
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difference (p = 0.281). The time from antibiotic initiation to peritonitis resolution was 
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also comparable between the study groups (  = 0.593). Both methods demonstrated 
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similar effectiveness in peritonitis management. This suggests that either antibiotic 
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allocated in APD bags or antibiotic allocated in a CAPD replacement in the afternoon 
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plus APD in the night may be utilized for antibiotic administration in long-term 
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automated peritoneal dialysis patients. Further research could explore additional factors 
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influencing treatment outcomes and optimize peritonitis management. 
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3. Results 
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Data from 64 patients were included in the analysis, as two patients in the 
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intervention group were lost to follow-up due to voluntary abandonment of dialytic 
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therapy. Therefore, each study arm comprised 32 patients. 
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The characteristics of the participants, stratified by the randomly assigned groups, 
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are presented in Table 1. No significant differences were observed between the study 
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arms in terms of demographic data or any of the 17 evaluated comorbid conditions. 
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Additionally, the profile of peritoneal dialysis use, including treatment length and 
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modality, was found to be homogeneous between the study arms. 
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Table 1. Characteristics of the study groups for selected variables, Mexico 2020 - 
2022 
Characteristic 
Intervention 
group 
Control Group 
  
Age (years) 
47.4 ± 14.6 
51.5 ± 16.9 
0.285 
Gender 
Female 
10 (31.3%) 
7 (21.9%) 
0.485 
Male 
22 (68.7%) 
25 (78.1%) 
 
Body Mass Index 
26.6 ± 4.9 
27.9 ± 6.0 
0.676 
Erythropoietin, weekly dose (IU) 
10,843 ± 5,548 
9,437 ± 5,593 
0.194 
PD, length of (months) 
36.0 ± 32.9 
30.3 ± 24.8 
0.747 
APD modality 
 
 
 
CCPD 
29 (90.6%) 
30 (93.8%) 
0.641 
INPD 
3 (9.4%) 
2 (6.3%) 
 
APD per day, duration (hours) 
9.5 ± 0.6 
9.6 ± 0.5 
0.972 
Exchanges per day (number) 
5.2 ± 0.8 
5.2 ± 0.9 
0.954 

 
Isolated pathogen 
13 (40.6%) 
11 (34.4%) 
 
No-isolated pathogen 
(75%) 
(84%) 
 
Personal history of: 
 
 
 
Tobacco use (yes) 
18 (56.3%) 
20 (62.5%) 
0.611 
Alcohol consumption (yes) 
22 (68.8%) 
24 (75.0%) 
0.578 
Type 2 diabetes mellitus (yes) 
15 (46.9%) 
21 (65.6%) 
0.131 
Diabetic foot (yes) 
4 (12.5%) 
8 (25.0%) 
0.200 
Diabetic retinopathy 
10 (31.3%) 
12 (37.5%) 
0.599 
Arterial hypertension (yes) 
31 (96.9%) 
31 (96.9%) 
1.000 
Ischemic heart disease (yes) 
3 (9.4%) 
4 (12.5%) 
0.120 
Stroke (yes) 
3 (9.4%) 
1 (3.1%) 
0.302 
Venous thrombosis (yes) 
2 (6.3%) 
1 (3.1%) 
0.554 
Hypertriglyceridemia (yes) 
19 (55.9%) 
15 (46.9%) 
0.316 
Hypercholesterolemia (yes) 
16 (50.0%) 
16 (50.0%) 
1.000 
Hyperuricemia (yes) 
9 (28.1%) 
8 (25.0%) 
0.777 
Cataract (yes) 
16 (50.0%) 
11 (34.4%) 
0.206 
Anemia (yes) 
29 (90.6%) 
29 (90.6%) 
1.000 
Catheter insertion site infection (yes) 
8 (25.0%) 
6 (18.8%) 
0.545 
Previous peritonitis episode (yes) 
20 (62.5%) 
17 (53.1%) 
0.448 
Abbreviations: APD, automated peritoneal dialysis; IU, international units; PD, 
peritoneal dialysis; CCPD, continuous cycling peritoneal dialysis; INPD, intermittent 
nocturnal peritoneal dialysis. The p-values from ji-squared or t-tests are presented, 
as appropriate. 
 
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The prevalence of a previous peritonitis episode was 62.5% (n = 20/32) in the 
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intervention group and 53.1% (n = 17/32) in the control group, with no statistically 
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significant difference (p = 0.448). None of the analyzed individuals received tidal 
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peritoneal dialysis (TPD). 
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Finally, peritonitis resolution was documented in 90.6% (  = 29/32; 95% confidence 
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interval [CI] 75.0 – 98.0%) of patients who received antibiotics through APD, and in 
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81.3% (  = 26/32; 95% CI 63.6 – 92.8%) of the control group. These proportions were 
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statistically similar (  = 0.281). The margin of non inferiority analysis was established at 
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30%, and the result was 9.3%, this limit represents a risk of 0.04, IC(-15.38%-16.38%) 
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power of 99.6%. 
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The average number of days taken from the commencement of antibiotic treatment 
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to the full resolution of peritonitis was 6.2 ± 2.9 and 5.7 ± 3.3 days for both the 
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intervention and control groups. However, this disparity did not exhibit statistical 
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significance (  = 0.593). 
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In the analysis of the etiological profile, E. coli, Staphylococcus epidermidis, 
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Staphylococcus aureus, Pseudomona, Klebsiella pneumoniae, Enterobacter cloacae, and E. coli 
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ESBL, were the predominant bacterium. In the control group etiological profile was 
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similar to intervention group p 0.23.  Notably, the study group exhibited no significant 
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differences in the distribution of identified microorganisms. 
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. 
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