Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05807217
Status:
RECRUITING
Last Update Posted:
2023-04-11
First Post:
2023-02-06
Brief Title:
A Pharmacokinetics Study of Meropenem and Piperacillin in Patients With Sepsis
Sponsor:
Shen Ning
Organization:
Peking University Third Hospital
Study Overview
Official Title:
A Study to Evaluate the Pharmacokinetics of Meropenem and Piperacillin in Patients With Sepsis
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APSOMAPIPWS
Brief Summary:
This study was a single-center open clinical study in Chinese septic patients with or without acute kidney injury The aims of this study were to obtain the blood concentration and pharmacokinetic parameters of meropenem and piperacillin exosome information and endogenous biomarker and to explore the functional changes of OATs under the condition of sepsis and acute kidney injury
Detailed Description:
The target population of this study was Chinese septic patients with or without acute kidney injury which were divided into five groups including group A of 12 patients receiving meropenem without acute kidney injury group B of 12 patients receiving meropenem without renal replacement therapy for acute kidney injury group C of 12 patients receiving meropenem with intermittent renal replacement therapy for acute kidney injury group D of 4 patients receiving meropenem with continuous renal replacement therapy for acute kidney injury and group E of 4 patients receiving piperacillin with intermittent renal replacement therapy for acute kidney injury All subjects who may participate in the study must sign informed consent form if one has no capacity for civil conduct the guardian will sign on behalf of him and the subjects who sign informed consent form will be screened for eligibility evaluation based on the inclusion criteria Waste blood samples if any obtained from blood biochemical or routine blood tests and urine if any were collected in all groups and residual urine volume within 24 hours was recorded Subjects were treated with the regimens of meropenem or piperacillin on study day D1 which were determined and implemented by the clinician according to the treatment guidelines Medications that may affect OAT function were not allowed during the study period evaluated and recorded by the clinician Venous blood was collected from all subjects at 0 h predose at 0 h 05 h 35 h Q8h or 55 h Q12h after the end of the infusion and within 30 min before next dose In addition to 4 mL of venous blood taken at 0 h predose 1 mL of venous blood should be collected at every other time point Meanwhile information of drug combination complications drug susceptibility pathogen detection demographic data and RRT parameters if any were also recorded during the period of this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None