Trial Outcomes & Findings for The Effects of Polymyxin-B Protects on Sepsis Induced Kidney Dysfunction: a Randomized Clinical Trial (NCT NCT00490477)
NCT ID: NCT00490477
Last Updated: 2010-06-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
16 participants
Primary outcome timeframe
28 days from the admission
Results posted on
2010-06-08
Participant Flow
Participant milestones
| Measure |
Conventional Treatment (CONV)
patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
|
Polymyxin-B Hemoperfusion Treatment (PMX-B)
patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Polymyxin-B Protects on Sepsis Induced Kidney Dysfunction: a Randomized Clinical Trial
Baseline characteristics by cohort
| Measure |
Conventional Treatment (CONV)
n=8 Participants
patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
|
Polymyxin-B Hemoperfusion Treatment (PMX-B)
n=8 Participants
patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Age Continuous
|
59 years
STANDARD_DEVIATION 13 • n=39 Participants
|
61 years
STANDARD_DEVIATION 10 • n=41 Participants
|
60 years
STANDARD_DEVIATION 11 • n=35 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Region of Enrollment
Italy
|
8 participants
n=39 Participants
|
8 participants
n=41 Participants
|
16 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 28 days from the admissionOutcome measures
| Measure |
Conventional Treatment (CONV)
n=8 Participants
patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
|
Polymyxin-B Hemoperfusion Treatment (PMX-B)
n=8 Participants
patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
|
|---|---|---|
|
Number of Participants Not Requiring Renal Replacement Therapy (RRT)
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 72 hours after randomizationOutcome measures
Outcome data not reported
Adverse Events
Conventional Treatment (CONV)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Polymyxin-B Hemoperfusion Treatment (PMX-B)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place