Trial Outcomes & Findings for PK/PD of High Dose Pip/Tazo in Obese Patients (NCT NCT01923363)
NCT ID: NCT01923363
Last Updated: 2018-10-26
Results Overview
Pharmacokinetic parameters for piperacillin of maximum serum concentration (Cmax) will be measured in both standard dosing and high dosing.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
0, 1, 3, and 6 hours post-dose
Results posted on
2018-10-26
Participant Flow
438 obese patients receiving P-T were screened between June 2013 and January 2016. 67 patients fit inclusion criteria - 12 chose not to participate in the study or informed consent could not be obtained; 9 were excluded due to refusal of the primary care team; 13 had P-T discontinued prior to enrollment; and 4 were included previously in the study
Participant milestones
| Measure |
Piperacillin/Tazobactam Standard to High Dose
Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
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|---|---|
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Overall Study
STARTED
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29
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Overall Study
COMPLETED
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28
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Piperacillin/Tazobactam Standard to High Dose
Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
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|---|---|
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Overall Study
Protocol Violation
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1
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Baseline Characteristics
Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
Baseline characteristics by cohort
| Measure |
Piperacillin/Tazobactam Standard to High Dose
n=28 Participants
Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
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|---|---|
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Age, Continuous
Group 1 (CrCl >/= 80mL/min)
|
46 years
n=12 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Age, Continuous
Group 2 (CrCl >/= 40 to < 80 mL/min)
|
57 years
n=8 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Age, Continuous
Group 3 (CrCl < 40)
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60 years
n=5 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Age, Continuous
Group 4 (Hemodialysis)
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42 years
n=3 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Sex: Female, Male
Female
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10 Participants
n=28 Participants
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Sex: Female, Male
Male
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18 Participants
n=28 Participants
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Region of Enrollment
United States
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28 participants
n=28 Participants
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Body Mass Index (BMI)
Group 1 (CrCl >/= 80 mL/min)
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41 kilograms per sqare meter
n=12 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Body Mass Index (BMI)
Group 2 (CrCl >/= 40 to < 80 mL/min)
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47 kilograms per sqare meter
n=8 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Body Mass Index (BMI)
Group 3 (CrCl < 40 mL/min)
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38 kilograms per sqare meter
n=5 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Body Mass Index (BMI)
Group 4 (Hemodialysis)
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49 kilograms per sqare meter
n=3 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Weight
Group 1 (CrCl >/= 80 mL/min)
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127 kilograms
n=12 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Weight
Group 2 (CrCl >/= 40 to < 80 mL/min)
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142 kilograms
n=8 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Weight
Group 3 (CrCl < 40 mL/min)
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121 kilograms
n=5 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Weight
Group 4 (Hemodialysis)
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136 kilograms
n=3 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Total Bilirubin
Group 1 (CrCl >/= 80 mL/min)
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0.6 milligrams per deciliter
n=12 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Total Bilirubin
Group 2 (CrCl >/= 40 to < 80 mL/min)
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0.8 milligrams per deciliter
n=8 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Total Bilirubin
Group 3 (CrCl < 40 mL/min)
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1.3 milligrams per deciliter
n=5 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Total Bilirubin
Group 4 (Hemodialysis)
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0.5 milligrams per deciliter
n=3 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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ICU Status
Group 1 (CrCl >/= 80 mL/min)
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6 Participants
n=12 Participants • Measure Analysis Population Description: Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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ICU Status
Group 2 (CrCl >/= 40 to < 80 mL/min)
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7 Participants
n=8 Participants • Measure Analysis Population Description: Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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ICU Status
Group 3 (CrCl < 40 mL/min)
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5 Participants
n=5 Participants • Measure Analysis Population Description: Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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ICU Status
Group 4 (Hemodialysis)
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3 Participants
n=3 Participants • Measure Analysis Population Description: Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II Score
Group 1 (CrCl >/= 80 mL/min)
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15.7 units on a scale
n=12 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II Score
Group 2 (CrCl >/= 40 to < 80 mL/min)
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16.6 units on a scale
n=8 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II Score
Group 3 (CrCl < 40 mL/min)
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22.8 units on a scale
n=5 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II Score
Group 4 (Hemodialysis)
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26.0 units on a scale
n=3 Participants • Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Sequential Organ Failure Assessment (SOFA) Score
Group 1 (CrCl >/= 80 mL/min)
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5.8 units on a scale
n=12 Participants • Measure Analysis Population Description: Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Sequential Organ Failure Assessment (SOFA) Score
Group 2 (CrCl >/= 40 to < 80 mL/min)
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7.4 units on a scale
n=8 Participants • Measure Analysis Population Description: Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Sequential Organ Failure Assessment (SOFA) Score
Group 3 (CrCl < 40 mL/min)
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9.4 units on a scale
n=5 Participants • Measure Analysis Population Description: Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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Sequential Organ Failure Assessment (SOFA) Score
Group 4 (Hemodialysis)
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9.3 units on a scale
n=3 Participants • Measure Analysis Population Description: Patients categorized by degree of renal function. The total number of patients is 28, divided into 4 different groups based on degree of renal insufficiency as measured by creatinine clearance (CrCl).
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PRIMARY outcome
Timeframe: 0, 1, 3, and 6 hours post-dosePopulation: The # of participants in the rows below will be double the overall participant number because each patient had two different dosing regimens of pip/tazo In Group 3, 4.5g group N = 5 represents low and high dose - 2 patients receiving 4.5g upon enrollment and increased to 6.75g; 3 patients were receiving either 2.25g or 3.375g and increased to 4.5g
Pharmacokinetic parameters for piperacillin of maximum serum concentration (Cmax) will be measured in both standard dosing and high dosing.
Outcome measures
| Measure |
Standard Dose to High Dose Piperacillin/Tazobactam
n=28 Participants
Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
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Serum Maximum Concentrations for Piperacillin
Group 1 (CrCl >/= 80 mL/min) on 3.375 grams
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136 milligrams per liter
Interval 107.0 to 179.0
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Serum Maximum Concentrations for Piperacillin
Group 1 (CrCl >/= 80 mL/min) on 4.5 grams
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190 milligrams per liter
Interval 149.0 to 247.0
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Serum Maximum Concentrations for Piperacillin
Group 1 (CrCl > 80 mL/min) on 6.75 grams
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237 milligrams per liter
Interval 96.4 to 368.0
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Serum Maximum Concentrations for Piperacillin
Group 1 (CrCl >/= 80 mL/min) on 9 grams
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332 milligrams per liter
Interval 283.0 to 417.0
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Serum Maximum Concentrations for Piperacillin
Group 2 (CrCl >/= 40 to < 80 mL/min) on 3.375 gram
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144 milligrams per liter
Interval 99.1 to 184.0
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Serum Maximum Concentrations for Piperacillin
Group 2 (CrCl >/= 40 to < 80 mL/min) on 4.5 grams
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214 milligrams per liter
Interval 211.0 to 215.0
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Serum Maximum Concentrations for Piperacillin
Group 2 (CrCl >/= 40 to < 80 mL/min) on 6.75 grams
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244 milligrams per liter
Interval 172.0 to 350.0
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Serum Maximum Concentrations for Piperacillin
Group 2 (CrCl >/= 40 to < 80 mL/min) on 9 grams
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191 milligrams per liter
Interval 191.0 to 191.0
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Serum Maximum Concentrations for Piperacillin
Group 3 (CrCl < 40 mL/min) on 2.25 grams
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176 milligrams per liter
Interval 94.6 to 258.0
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Serum Maximum Concentrations for Piperacillin
Group 3 (CrCl < 40 mL/min) on 3.375 grams
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296 milligrams per liter
Interval 296.0 to 296.0
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Serum Maximum Concentrations for Piperacillin
Group 3 (CrCl < 40 mL/min) on 4.5 grams
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265 milligrams per liter
Interval 163.0 to 327.0
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Serum Maximum Concentrations for Piperacillin
Group 3 (CrCl < 40 mL/min) on 6.75 grams
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299 milligrams per liter
Interval 287.0 to 312.0
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Serum Maximum Concentrations for Piperacillin
Group 4 (HD) on 2.25 grams
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158 milligrams per liter
Interval 142.0 to 173.0
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Serum Maximum Concentrations for Piperacillin
Group 4 (HD) on 3.375 grams
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223 milligrams per liter
Interval 223.0 to 223.0
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Serum Maximum Concentrations for Piperacillin
Group 4 (HD) on 4.5 grams
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275 milligrams per liter
Interval 275.0 to 275.0
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Serum Maximum Concentrations for Piperacillin
Group 4 (HD) on 6.75 grams
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397 milligrams per liter
Interval 304.0 to 490.0
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PRIMARY outcome
Timeframe: 0, 1, 3, and 6 hours post-dosePopulation: The # of participants in the rows below will be double the overall participant number because each patient had two different dosing regimens of pip/tazo In Group 3, 4.5g group N = 5 represents low and high dose - 2 patients receiving 4.5g upon enrollment and increased to 6.75g; 3 patients were receiving either 2.25g or 3.375g and increased to 4.5g
Minimum serum concentrations (Cmin) of piperacillin will be measured in both standard and high doses
Outcome measures
| Measure |
Standard Dose to High Dose Piperacillin/Tazobactam
n=28 Participants
Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
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|---|---|
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Serum Minimum Concentrations of Piperacillin
Group 1 (CrCl >/= 80 mL/min) on 9 grams
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10.3 milligrams per liter
Interval 0.57 to 29.4
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Serum Minimum Concentrations of Piperacillin
Group 2 (CrCl >/= 40 to 80 mL/min) on 3.375 grams
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47.4 milligrams per liter
Interval 24.1 to 75.4
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Serum Minimum Concentrations of Piperacillin
Group 2 (CrCl >/= 40 to 80 mL/min) on 4.5 grams
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52.5 milligrams per liter
Interval 49.4 to 55.6
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Serum Minimum Concentrations of Piperacillin
Group 2 (CrCl >/= 40 to 80 mL/min) on 6.75 grams
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72.6 milligrams per liter
Interval 37.5 to 128.0
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Serum Minimum Concentrations of Piperacillin
Group 3 (CrCl < 40 mL/min) on 3.375 grams
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207 milligrams per liter
Interval 207.0 to 207.0
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Serum Minimum Concentrations of Piperacillin
Group 3 (CrCl < 40 mL/min) on 4.5 grams
|
142 milligrams per liter
Interval 31.1 to 223.0
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Serum Minimum Concentrations of Piperacillin
Group 3 (CrCl < 40 mL/min) on 6.75 grams
|
148 milligrams per liter
Interval 135.0 to 162.0
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Serum Minimum Concentrations of Piperacillin
Group 1 (CrCl >/= 80 mL/min) on 3.375 grams
|
8.9 milligrams per liter
Interval 0.0 to 44.1
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Serum Minimum Concentrations of Piperacillin
Group 1 (CrCl >/= 80 mL/min) on 4.5 grams
|
11.1 milligrams per liter
Interval 1.4 to 18.2
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Serum Minimum Concentrations of Piperacillin
Group 1 (CrCl >/= 80 mL/min) on 6.75 grams
|
27.0 milligrams per liter
Interval 8.6 to 72.6
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Serum Minimum Concentrations of Piperacillin
Group 2 (CrCl >/= 40 to 80 mL/min) on 9 grams
|
54.1 milligrams per liter
Interval 54.1 to 54.1
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Serum Minimum Concentrations of Piperacillin
Group 3 (CrCl < 40 mL/min) on 2.25 grams
|
78.8 milligrams per liter
Interval 14.5 to 143.0
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Serum Minimum Concentrations of Piperacillin
Group 4 (HD) on 2.25 grams
|
99 milligrams per liter
Interval 79.6 to 118.0
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Serum Minimum Concentrations of Piperacillin
Group 4 (HD) on 3.375 grams
|
143 milligrams per liter
Interval 143.0 to 143.0
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Serum Minimum Concentrations of Piperacillin
Group 4 (HD) on 4.5 grams
|
181 milligrams per liter
Interval 181.0 to 181.0
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Serum Minimum Concentrations of Piperacillin
Group 4 (HD) on 6.75 grams
|
234 milligrams per liter
Interval 193.0 to 274.0
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SECONDARY outcome
Timeframe: 0, 1, 3, and 6 hours post-dosePopulation: The # of participants in the rows below will be double the overall participant number because each patient had two different dosing regimens of pip/tazo In Group 3, 4.5g group N = 5 represents low and high dose - 2 patients receiving 4.5g upon enrollment and increased to 6.75g; 3 patients were receiving either 2.25g or 3.375g and increased to 4.5g
Half-life (t1/2) of piperacillin will be calculated from serum concentrations in both standard and high doses
Outcome measures
| Measure |
Standard Dose to High Dose Piperacillin/Tazobactam
n=28 Participants
Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
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|---|---|
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Half-life of Piperacillin
Group 1 (CrCl >/= 80 mL/min) on 3.375 grams
|
1.2 hours
Interval 0.5 to 2.7
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Half-life of Piperacillin
Group 2 (CrCl >/= 40 to < 80 mL/min) on 4.5 grams
|
2.7 hours
Interval 2.6 to 2.7
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Half-life of Piperacillin
Group 2 (CrCl >/= 40 to < 80 mL/min) on 6.75 grams
|
3.8 hours
Interval 2.2 to 9.4
|
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Half-life of Piperacillin
Group 1 (CrCl >/= 80 mL/min) on 4.5 grams
|
1.5 hours
Interval 0.8 to 2.4
|
|
Half-life of Piperacillin
Group 1 (CrCl >/= 80 mL/min) on 6.75 grams
|
1.8 hours
Interval 1.1 to 3.0
|
|
Half-life of Piperacillin
Group 1 (CrCl >/= 80 mL/min) on 9 grams
|
0.9 hours
Interval 0.6 to 1.4
|
|
Half-life of Piperacillin
Group 2 (CrCl >/= 40 to < 80 mL/min) on 3.375 gram
|
3.9 hours
Interval 1.9 to 6.8
|
|
Half-life of Piperacillin
Group 2 (CrCl >/= 40 to < 80 mL/min) on 9 grams
|
2.5 hours
Interval 2.5 to 2.5
|
|
Half-life of Piperacillin
Group 3 (CrCl < 40 mL/min) on 2.25 grams
|
4.3 hours
Interval 2.0 to 6.5
|
|
Half-life of Piperacillin
Group 3 (CrCl < 40 mL/min) on 3.375 grams
|
10.7 hours
Interval 10.7 to 10.7
|
|
Half-life of Piperacillin
Group 3 (CrCl < 40 mL/min) on 4.5 grams
|
6.2 hours
Interval 2.3 to 10.6
|
|
Half-life of Piperacillin
Group 3 (CrCl < 40 mL/min) on 6.75 grams
|
5.5 hours
Interval 5.1 to 5.8
|
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Half-life of Piperacillin
Group 4 (HD) on 2.25 grams
|
9.8 hours
Interval 9.8 to 9.8
|
|
Half-life of Piperacillin
Group 4 (HD) on 3.375 grams
|
8.6 hours
Interval 8.6 to 8.6
|
|
Half-life of Piperacillin
Group 4 (HD) on 4.5 grams
|
9.1 hours
Interval 9.1 to 9.1
|
|
Half-life of Piperacillin
Group 4 (HD) on 6.75 grams
|
7.4 hours
Interval 6.5 to 8.4
|
SECONDARY outcome
Timeframe: 0, 1, 3, and 6 hours post-dosePopulation: The # of participants in the rows below will be double the overall participant number because each patient had two different dosing regimens of pip/tazo In Group 3, 4.5g group N = 5 represents low and high dose - 2 patients receiving 4.5g upon enrollment and increased to 6.75g; 3 patients were receiving either 2.25g or 3.375g and increased to 4.5g
Volume of distribution (Vd) of piperacillin will be calculated from serum concentrations in both standard and high doses
Outcome measures
| Measure |
Standard Dose to High Dose Piperacillin/Tazobactam
n=28 Participants
Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
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|---|---|
|
Volume of Distribution of Piperacillin
Group 2 (CrCl >/= 40 to < 80 mL/min) on 9 gram
|
48.8 liters
Interval 48.8 to 48.8
|
|
Volume of Distribution of Piperacillin
Group 3 (CrCl < 40mL/min) on 2.25 grams
|
22.9 liters
Interval 16.9 to 28.8
|
|
Volume of Distribution of Piperacillin
Group 3 (CrCl < 40mL/min) on 3.375 grams
|
30.5 liters
Interval 30.5 to 30.5
|
|
Volume of Distribution of Piperacillin
Group 1 (CrCl >/= 80 mL/min) on 3.375 grams
|
19.0 liters
Interval 14.1 to 24.7
|
|
Volume of Distribution of Piperacillin
Group 1 (CrCl >/= 80 mL/min) on 4.5 grams
|
20.9 liters
Interval 13.6 to 27.6
|
|
Volume of Distribution of Piperacillin
Group 1 (CrCl >/= 80 mL/min) on 6.75 grams
|
27.7 liters
Interval 14.9 to 61.0
|
|
Volume of Distribution of Piperacillin
Group 1 (CrCl >/= 80 mL/min) on 9 grams
|
20.1 liters
Interval 17.3 to 22.3
|
|
Volume of Distribution of Piperacillin
Group 2 (CrCl >/= 40 to < 80 mL/min) on 3.375 gram
|
31.6 liters
Interval 20.4 to 54.8
|
|
Volume of Distribution of Piperacillin
Group 2 (CrCl >/= 40 to < 80 mL/min) on 4.5 gram
|
20.3 liters
Interval 19.3 to 21.3
|
|
Volume of Distribution of Piperacillin
Group 2 (CrCl >/= 40 to < 80 mL/min) on 6.75 gram
|
31.7 liters
Interval 18.3 to 54.5
|
|
Volume of Distribution of Piperacillin
Group 3 (CrCl < 40mL/min) on 4.5 grams
|
26.3 liters
Interval 20.0 to 32.9
|
|
Volume of Distribution of Piperacillin
Group 3 (CrCl < 40mL/min) on 6.75 grams
|
29.9 liters
Interval 23.5 to 36.3
|
|
Volume of Distribution of Piperacillin
Group 4 (HD) on 2.25 grams
|
34.9 liters
Interval 34.9 to 34.9
|
|
Volume of Distribution of Piperacillin
Group 4 (HD) on 3.375 grams
|
28.9 liters
Interval 28.9 to 28.9
|
|
Volume of Distribution of Piperacillin
Group 4 (HD) on 4.5 grams
|
24.6 liters
Interval 24.6 to 24.6
|
|
Volume of Distribution of Piperacillin
Group 4 (HD) on 6.75 grams
|
34.0 liters
Interval 29.7 to 38.3
|
Adverse Events
Standard Dose to High Dose Piperacillin/Tazobactam
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Dose to High Dose Piperacillin/Tazobactam
n=29 participants at risk
Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
Piperacillin/Tazobactam Standard Dose to High Dose: Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Patients will be switched to higher dose after receiving the standard dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
|
|---|---|
|
Gastrointestinal disorders
Nausea and vomiting
|
3.4%
1/29 • Number of events 1 • Each patient was monitored daily for adverse reactions from study enrollment until two weeks after piperacillin-tazobactam was discontinued or until hospital discharge, whichever was sooner
Pertinent lab values followed for signs of acute renal impairment, liver impairment, or hematologic abnormalities. Adverse reactions were promptly reported to the primary team and IRB. If study drug suspected to be responsible for an adverse reaction, the drug discontinued at the discretion of the primary care team. There were no deaths out of the 28 subjects at risk of death during study enrollment.
|
Other adverse events
| Measure |
Standard Dose to High Dose Piperacillin/Tazobactam
n=29 participants at risk
Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
Piperacillin/Tazobactam Standard Dose to High Dose: Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Patients will be switched to higher dose after receiving the standard dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
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Renal and urinary disorders
Acute Kidney Injury
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6.9%
2/29 • Number of events 2 • Each patient was monitored daily for adverse reactions from study enrollment until two weeks after piperacillin-tazobactam was discontinued or until hospital discharge, whichever was sooner
Pertinent lab values followed for signs of acute renal impairment, liver impairment, or hematologic abnormalities. Adverse reactions were promptly reported to the primary team and IRB. If study drug suspected to be responsible for an adverse reaction, the drug discontinued at the discretion of the primary care team. There were no deaths out of the 28 subjects at risk of death during study enrollment.
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Gastrointestinal disorders
Nausea
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3.4%
1/29 • Number of events 1 • Each patient was monitored daily for adverse reactions from study enrollment until two weeks after piperacillin-tazobactam was discontinued or until hospital discharge, whichever was sooner
Pertinent lab values followed for signs of acute renal impairment, liver impairment, or hematologic abnormalities. Adverse reactions were promptly reported to the primary team and IRB. If study drug suspected to be responsible for an adverse reaction, the drug discontinued at the discretion of the primary care team. There were no deaths out of the 28 subjects at risk of death during study enrollment.
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Gastrointestinal disorders
Abdominal Pain
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3.4%
1/29 • Number of events 1 • Each patient was monitored daily for adverse reactions from study enrollment until two weeks after piperacillin-tazobactam was discontinued or until hospital discharge, whichever was sooner
Pertinent lab values followed for signs of acute renal impairment, liver impairment, or hematologic abnormalities. Adverse reactions were promptly reported to the primary team and IRB. If study drug suspected to be responsible for an adverse reaction, the drug discontinued at the discretion of the primary care team. There were no deaths out of the 28 subjects at risk of death during study enrollment.
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Gastrointestinal disorders
Diarrhea
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3.4%
1/29 • Number of events 1 • Each patient was monitored daily for adverse reactions from study enrollment until two weeks after piperacillin-tazobactam was discontinued or until hospital discharge, whichever was sooner
Pertinent lab values followed for signs of acute renal impairment, liver impairment, or hematologic abnormalities. Adverse reactions were promptly reported to the primary team and IRB. If study drug suspected to be responsible for an adverse reaction, the drug discontinued at the discretion of the primary care team. There were no deaths out of the 28 subjects at risk of death during study enrollment.
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Psychiatric disorders
Delirium
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3.4%
1/29 • Number of events 1 • Each patient was monitored daily for adverse reactions from study enrollment until two weeks after piperacillin-tazobactam was discontinued or until hospital discharge, whichever was sooner
Pertinent lab values followed for signs of acute renal impairment, liver impairment, or hematologic abnormalities. Adverse reactions were promptly reported to the primary team and IRB. If study drug suspected to be responsible for an adverse reaction, the drug discontinued at the discretion of the primary care team. There were no deaths out of the 28 subjects at risk of death during study enrollment.
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Additional Information
Dr. Steven Forland
Loma Linda University Medical Center
Phone: 909-558-4000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place