End Stage Renal Disease
Conditions
Keywords
ertapenem, pharmacokinetic, pharmacodynamics, hemodialysis, requires hemodialysis three times a week
Brief summary
The purpose of this study is to determine the amount of ertapenem in the blood over time between hemodialysis session.
Detailed description
After a hemodialysis session, subject will be administered ertapenem and the amount of ertapenem in the blood will be measured at seven time periods before the initiation of the next hemodialysis session.
Interventions
DRUGErtapenem
Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn
Sponsors
Wayne State University
Corewell Health East
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
No
Inclusion criteria
* Men or women age between 18 and 88 at the time of admission to Oakwood Hospital and Medical Center during January 1, 2014 or date of Institutional Review Board (IRB) approval to December 1, 2015 * Diagnosed with end stage renal disease and requires hemodialysis three times a week * No allergy to β lactam medications * Existing IV access for parenteral ertapenem infusion * Willing for blood draws, at predose, 0.5, 1, 2, 6, 12 hours post-hemodialysis and pre-hemodialysis for the following hemodialysis and immediately post hemodialysis session and 1 hour post. * No evidence of hepatic disease * No history of alcoholism or drug abuse within pervious 2 years * Not pregnant
Exclusion criteria
* History of any form of epilepsy, seizure or convulsion * Currently taking any forms of valproic acid or divalproex sodium for treatment of any disease states * Currently taking probenecid * Current Clostridium difficile (C. diff.) infection, defined as 30 days prior to day-1 of receiving ertapenem for this study * Currently receiving any antimicrobial agents for prophylaxis or treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time to Cmax of Ertapenem in Hemodialysis Patients | once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session | Mean time to Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session |
| Mean Maximum Concentration (Cmax) of Ertapenem in Hemodialysis Patients | once after hemodialysis session prior to ertapenem administration and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session | Mean Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session |
| Mean Minimum Concentration (Cmin) of Ertapenem in Hemodialysis Patients | once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session | Mean Cmin will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session |
| Mean Area Under the Curve (AUC) of Ertapenem in Hemodialysis Patients | once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session | Mean AUC will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session |
| Mean Terminal Half Life (t1/2) of Ertpenem in Hemodialysis Patients | once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session | Mean t1/2 will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Diarrhea | Up to seven days after the administration of ertapenem | Evaluation of diarrhea will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital |
| Number of Participants With Nausea and Vomiting | Up to seven days after the administration of ertapenem | Evaluation of nausea and vomiting will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital |
| Number of Participants With Headache | Up to seven days after the administration of ertapenem | Evaluation of headache will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital |
| Number of Participants With Injection Site Reaction | Up to seven days after the administration of ertapenem | Evaluation of injection site reaction will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Events | Up to seven days after the administration of ertapenem | Evaluation of any adverse events will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ertapenem Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Ertapenem |
|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 11.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 7 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 5 Participants |
| weight | 77.7 kilograms STANDARD_DEVIATION 18.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 6 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Mean Area Under the Curve (AUC) of Ertapenem in Hemodialysis Patients
Mean AUC will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Time frame: once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertapenem | Mean Area Under the Curve (AUC) of Ertapenem in Hemodialysis Patients | 6225 h*ug/mL | Standard Deviation 1259 |
Primary
Mean Maximum Concentration (Cmax) of Ertapenem in Hemodialysis Patients
Mean Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Time frame: once after hemodialysis session prior to ertapenem administration and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertapenem | Mean Maximum Concentration (Cmax) of Ertapenem in Hemodialysis Patients | 663.1 mcg/ml | Standard Deviation 904.9 |
Primary
Mean Minimum Concentration (Cmin) of Ertapenem in Hemodialysis Patients
Mean Cmin will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Time frame: once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertapenem | Mean Minimum Concentration (Cmin) of Ertapenem in Hemodialysis Patients | 44.3 mcg/ml | Standard Deviation 14.5 |
Primary
Mean Terminal Half Life (t1/2) of Ertpenem in Hemodialysis Patients
Mean t1/2 will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Time frame: once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertapenem | Mean Terminal Half Life (t1/2) of Ertpenem in Hemodialysis Patients | 19.3 hours | Standard Deviation 6.6 |
Primary
Mean Time to Cmax of Ertapenem in Hemodialysis Patients
Mean time to Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Time frame: once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertapenem | Mean Time to Cmax of Ertapenem in Hemodialysis Patients | 0.5 hours | Standard Deviation 0 |
Secondary
Number of Participants With Diarrhea
Evaluation of diarrhea will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital
Time frame: Up to seven days after the administration of ertapenem
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ertapenem | Number of Participants With Diarrhea | 1 Participants |
Secondary
Number of Participants With Headache
Evaluation of headache will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital
Time frame: Up to seven days after the administration of ertapenem
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ertapenem | Number of Participants With Headache | 0 Participants |
Secondary
Number of Participants With Injection Site Reaction
Evaluation of injection site reaction will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital
Time frame: Up to seven days after the administration of ertapenem
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ertapenem | Number of Participants With Injection Site Reaction | 0 Participants |
Secondary
Number of Participants With Nausea and Vomiting
Evaluation of nausea and vomiting will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital
Time frame: Up to seven days after the administration of ertapenem
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ertapenem | Number of Participants With Nausea and Vomiting | 1 Participants |
Other Pre-specified
Number of Participants With Any Adverse Events
Evaluation of any adverse events will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital
Time frame: Up to seven days after the administration of ertapenem
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ertapenem | Number of Participants With Any Adverse Events | 6 Participants |