Trial Outcomes & Findings for Treatment of Peritonitis in Automated Peritoneal Dialysis (NCT NCT04077996)
NCT ID: NCT04077996
Last Updated: 2025-03-26
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
14 to 21 days
Results posted on
2025-03-26
Participant Flow
71 patients were diagnosed with peritonitis. 7 patients were excluded because, 5 patients did not meet criteria and 2 voluntary abandonment
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lost to follow-up two patients in the intervention group
Baseline characteristics by cohort
| Measure |
Peritonitis Treatment With One Exchange in CAPD
n=32 Participants
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.
|
Peritonitis Treatment Placed in APD
n=32 Participants
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.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants • Lost to follow-up two patients in the intervention group
|
0 Participants
n=107 Participants • Lost to follow-up two patients in the intervention group
|
0 Participants
n=206 Participants • Lost to follow-up two patients in the intervention group
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=99 Participants • Lost to follow-up two patients in the intervention group
|
29 Participants
n=107 Participants • Lost to follow-up two patients in the intervention group
|
56 Participants
n=206 Participants • Lost to follow-up two patients in the intervention group
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants • Lost to follow-up two patients in the intervention group
|
3 Participants
n=107 Participants • Lost to follow-up two patients in the intervention group
|
8 Participants
n=206 Participants • Lost to follow-up two patients in the intervention group
|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 16.9 • n=99 Participants
|
47.4 years
STANDARD_DEVIATION 4.6 • n=107 Participants
|
49.42 years
STANDARD_DEVIATION 72.64 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
spanish race
|
32 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Region of Enrollment
Mexico
|
32 participants
n=99 Participants
|
32 participants
n=107 Participants
|
64 participants
n=206 Participants
|
|
APD modality
CCPD, continuous cycling peritoneal dialysi
|
30 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
APD modality
INPD, intermittent nocturnal peritoneal dialysis
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Body Mass Index
|
27.9 kg/m^2
STANDARD_DEVIATION 6.0 • n=99 Participants
|
26.6 kg/m^2
STANDARD_DEVIATION 4.9 • n=107 Participants
|
27.23 kg/m^2
STANDARD_DEVIATION 5.49 • n=206 Participants
|
|
APD per day, duration (hours)
|
9.6 Hours
STANDARD_DEVIATION 0.5 • n=99 Participants
|
9.5 Hours
STANDARD_DEVIATION 0.6 • n=107 Participants
|
9.55 Hours
STANDARD_DEVIATION 0.56 • n=206 Participants
|
|
Exchanges per day (number)
|
5.2 Exchanges per day (number)
STANDARD_DEVIATION 0.9 • n=99 Participants
|
5.2 Exchanges per day (number)
STANDARD_DEVIATION 0.8 • n=107 Participants
|
5.2 Exchanges per day (number)
STANDARD_DEVIATION 0.87 • n=206 Participants
|
|
Tobacco use (yes)
|
20 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Alcohol consumption (yes)
Alcohol consumption
|
24 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Alcohol consumption (yes)
No Alcohol consumption
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Type 2 diabetes mellitus (yes)
|
21 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Arterial hypertension (yes)
|
31 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Hypertriglyceridemia (yes
|
15 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Hypercholesterolemia (yes
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Hyperuricemia (yes)
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Anemia (yes)
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Previous peritonitis episode (yes)
|
17 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 14 to 21 daysPopulation: non-inferiority and the intent-to-treat
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)
Outcome measures
| Measure |
Peritonitis Treatment With ANTIBIOTIC in a Exchange in CAPD + Usual APD
n=32 Participants
Antibiotic treatment (ceftazidime (1500mg/day) and vancomycin (20mg/kg every 3 days) for 14 to 21 day) into an exchange on CAPD per day + usual APD.
|
Peritonitis Treatment Placed in APD
n=32 Participants
Antibiotic treatment placed in Automated Peritoneal Dialysis bags. (ceftazidime (1500mg/day) and vancomycin (20mg/kg every 3 days) for 14 to 21 days.
|
|---|---|---|
|
Peritonitis Resolved
|
26 participants
|
29 participants
|
SECONDARY outcome
Timeframe: 21 daysTotal number and percentage of patients
Outcome measures
| Measure |
Peritonitis Treatment With ANTIBIOTIC in a Exchange in CAPD + Usual APD
n=32 Participants
Antibiotic treatment (ceftazidime (1500mg/day) and vancomycin (20mg/kg every 3 days) for 14 to 21 day) into an exchange on CAPD per day + usual APD.
|
Peritonitis Treatment Placed in APD
n=32 Participants
Antibiotic treatment placed in Automated Peritoneal Dialysis bags. (ceftazidime (1500mg/day) and vancomycin (20mg/kg every 3 days) for 14 to 21 days.
|
|---|---|---|
|
Death of Patient
|
2 Participants
|
2 Participants
|
Adverse Events
Peritonitis Treatment With One Exchange in CAPD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Peritonitis Treatment Placed in APD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jesus Venegas-Ramírez
Instituto Mexicano del Seguro Social
Phone: 3143058373
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place