Trial Outcomes & Findings for Intradialytic Drug Removal by Short-daily Hemodialysis (NCT NCT00596167)
NCT ID: NCT00596167
Last Updated: 2016-03-25
Results Overview
The intradialytic clearance of levofloxacin, gentamicin and vancomycin will be determined in patients receiving short-daily hemodialysis. (Of important note, due to technical issues the levofloxacin data was not able to be used for the analysis. Only the gentamicin and vancomycin data was analyzed.)
COMPLETED
NA
6 participants
Serum concentrations for each drug will be determined from blood samples at 0 (pre-infusion), 30, 60 minutes (end of infusion).
2016-03-25
Participant Flow
Subjects were recruited from the Indiana University School of Medicine Short-daily hemodialysis clinic. The recruitment spanned 2007 to 2009. A total of six subjects were recruited.
Following completion of a subject's scheduled HD treatment, intravenous access will be maintained.
Participant milestones
| Measure |
Intravenous Antibiotics
This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intradialytic Drug Removal by Short-daily Hemodialysis
Baseline characteristics by cohort
| Measure |
Intravenous Antibiotics
n=6 Participants
This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Serum concentrations for each drug will be determined from blood samples at 0 (pre-infusion), 30, 60 minutes (end of infusion).The intradialytic clearance of levofloxacin, gentamicin and vancomycin will be determined in patients receiving short-daily hemodialysis. (Of important note, due to technical issues the levofloxacin data was not able to be used for the analysis. Only the gentamicin and vancomycin data was analyzed.)
Outcome measures
| Measure |
Intravenous Antibiotic (Vancomycin)
n=6 Participants
This study will have only one arm. All six participants in the study will receive an intravenous dose of the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
|
|---|---|
|
Intradialytic Clearance of Levofloxacin, Gentamicin and Vancomycin in Patients Receiving Short-daily Hemodialysis
Intravenous antibiotic (vancomycin)
|
7.2 ml/min
Interval 5.3 to 10.0
|
|
Intradialytic Clearance of Levofloxacin, Gentamicin and Vancomycin in Patients Receiving Short-daily Hemodialysis
Intravenous antibiotic (gentamicin)
|
7.6 ml/min
Interval 2.1 to 13.1
|
Adverse Events
Intravenous Antibiotics
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian Decker MD, PharmD
Indiana University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place