SepsisAPSOMAPIPWSNCT05807217
A Pharmacokinetics Study of Meropenem and Piperacillin in Patients With Sepsis
An observational study of Sepsis and Acute Kidney Injury, run by Shen Ning at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Acute Kidney Injury
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese septic patients with or without acute kidney injury
Who may be able to join
- Male or female, aged above 18 years old;
- Diagnosed with sepsis or septic shock;
- Body mass index (BMI) between 15-32 kg/m2 (male with the weight of > 45 kg and female with the weight of > 40 kg);
- Patients should be able to understand and sign the ICF voluntarily (if one has no capacity for civil conduct, the guardian will sign on behalf of him) and comply with the research restrictions.
- A diagnosis of AKI by the criteria of KDIGO for Group B, C, D and E;
- The pathogenic pathogen isolated or judged by attending physician to be susceptible to meropenem or piperacillin.
- RRT can be performed for Group C, D and E.
Who cannot join
- Be allergic to carbapenems and other β-lactam drugs or a history of allergy to those drugs;
- Currently diagnosed as malignant tumor;
- Women who are pregnant or breastfeeding;
- Receiving ECMO during RRT;
- Patients with severe liver insufficiency (Child-Pugh grade C);
- Patients with eGFR of < 15 mL/min/1.73 m2 and receive regular dialysis treatment;
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- A history of alcohol or drug abuse or a behavior of alcohol or drug abuse within the past six months;
- Patients who have taken or injected probenecid, gentamicin and streptomycin within 14 days before administration;
- Patients who have taken or injected vitamin B6 for 14 days before administration to the trial period;
- Poor peripheral venous access or intolerance to venous blood collection;
- Meet one of the following conditions: human immunodeficiency virus (HIV), hepatitis B virus (HBV) surface antigen positive (except C antibody was positive), hepatitis C virus (HCV) or syphilis positive;
- Patients who had a history of kidney transplantation or nephrectomy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Dongyang Liu, liudongyang@vip.sina.com
About this study
Official title: A Study to Evaluate the Pharmacokinetics of Meropenem and Piperacillin in Patients With Sepsis
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.
Read the 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, 0.5 h, 3.5 h (Q8h) or 5.5 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.
- Conditions
- Sepsis, Acute Kidney Injury
- Keywords
- sepsis, organic anion transporter, acute kidney injury, quantitative pharmacology, anti-infective drug
- Medical subject headings
- Sepsis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | 12 patients (receiving meropenem) without acute kidney injury | |
| Group B | 12 patients (receiving meropenem) without renal replacement therapy for acute kidney injury | |
| Group C | 12 patients (receiving meropenem) with intermittent renal replacement therapy for acute kidney injury | |
| Group D | 4 patients (receiving meropenem) with continuous renal replacement therapy for acute kidney injury | |
| Group E | 4 patients (receiving piperacillin) with intermittent renal replacement therapy for acute kidney injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of meropenem
Measured: Baseline and within 24 hours after administration
Dialysate concentration of meropenem
Measured: One day
Plasma concentration of piperacillin
Measured: Baseline and within 24 hours after administration
Dialysate concentration of piperacillin
Measured: One day
Secondary outcomes (1)
Plasma concentration of pyridoxic acid
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start26 Oct 2022
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shen Ning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shen Ning, Peking University Third Hospital
- Investigators
- Ning shen, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807217
- Sponsor's protocol ID
- DCTC-IIR 202215
- Acronym
- APSOMAPIPWS
- Status last verified
- Mar 2023
- First submitted
- 6 Feb 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Pharmacokinetics of Meropenem and Piperacillin in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT05807217
- Acronym / sponsor ID
- APSOMAPIPWS / DCTC-IIR 202215
- Conditions
- Sepsis, Acute Kidney Injury
- Keywords
- sepsis, organic anion transporter, acute kidney injury, quantitative pharmacology, anti-infective drug
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Shen NingUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 0.5 h, 3.5 h (Q8h) or 5.5 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –12 patients (receiving meropenem) without acute kidney injury |
| Group B | – | –12 patients (receiving meropenem) without renal replacement therapy for acute kidney injury |
| Group C | – | –12 patients (receiving meropenem) with intermittent renal replacement therapy for acute kidney injury |
| Group D | – | –4 patients (receiving meropenem) with continuous renal replacement therapy for acute kidney injury |
| Group E | – | –4 patients (receiving piperacillin) with intermittent renal replacement therapy for acute kidney injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese septic patients with or without acute kidney injury
Key inclusion criteria (7 listed)
- Male or female, aged above 18 years old;
- Diagnosed with sepsis or septic shock;
- Body mass index (BMI) between 15-32 kg/m2 (male with the weight of > 45 kg and female with the weight of > 40 kg);
- Patients should be able to understand and sign the ICF voluntarily (if one has no capacity for civil conduct, the guardian will sign on behalf of him) and comply with the research restrictions.
- A diagnosis of AKI by the criteria of KDIGO for Group B, C, D and E;
Key exclusion criteria (12 listed)
- Be allergic to carbapenems and other β-lactam drugs or a history of allergy to those drugs;
- Currently diagnosed as malignant tumor;
- Women who are pregnant or breastfeeding;
- Receiving ECMO during RRT;
- Patients with severe liver insufficiency (Child-Pugh grade C);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma concentration of meropenem
Time frame: Baseline and within 24 hours after administration
Dialysate concentration of meropenem
Time frame: One day
Plasma concentration of piperacillin
Time frame: Baseline and within 24 hours after administration
Dialysate concentration of piperacillin
Time frame: One day
1 secondary outcome
Plasma concentration of pyridoxic acid
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning shen principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Acute Kidney Injury, run by Shen Ning at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongyang Liu ((86)010-82266658, liudongyang@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration of meropenem (time frame: Baseline and within 24 hours after administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.