LaparotomyPK-LAPNCT04915872
Are Standard Dosing Regimens of Piperacillin-Tazobactam Suitable in Critically Ill Patients With Open Abdomen and Negative Pressure Wound Therapy? A Population Pharmacokinetic Study.
An observational study of Laparotomy and Critical Illness, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
For several years, open abdomen with temporary abdominal closure using Negative Pressure Therapy (OA/NPT) has become one of the leading strategies to treat or prevent intra-abdominal hypertension in critically ill surgical patients after a wide range of complex abdominal injuries and conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparotomy, Critical Illness, Piperacillin, Tazobactam Drug Combination
- What is being tested?
- Blood sampling (T0, inclusion) and other samplings (T1)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 27 Jan 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: Critically Ill Patients with Open Abdomen and Negative Pressure Wound Therapy
Who may be able to join
- Age ≥ 18
- Admitted in surgical ICU for a suspected length of stay > 3 days
- Receiving an antimicrobial therapy by PTZ
- For an intra-abdominal infection
- Under OA/NPT during antimicrobial therapy
- With urinary and arterial catheters
Who cannot join
- Severe renal failure (CLCR < 30 ml/min) without indication for continuous renal replacement therapy (CRRT)
- Known allergy to PTZ
- Patient's refusal for participation to the research
- Patient unable to consent (dementia or severe psychiatric disorders, people under legal protection, people deprived of their liberty...)
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
For several years, open abdomen with temporary abdominal closure using Negative Pressure Therapy (OA/NPT) has become one of the leading strategies to treat or prevent intra-abdominal hypertension in critically ill surgical patients after a wide range of complex abdominal injuries and conditions.
According to current practice, piperacillin-tazobactam (PTZ) is widely used as part of empirical combined antibiotic therapy to treat severe abdominal infections in the critically ill patients. On the other hand, little is known about the impact of OA/NPT on antibiotics pharmacokinetics and pharmacodynamics (PK/PD) and the optimal dosing regimens in this population remain unclear.
Read more
As PTZ is a small hydrophilic molecule with a very low level of protein binding, invesitigators hypothesized that OA/NPT should lead to significant changes in volume of distribution (Vd) and/or drug clearance (CL
The main objective of this study was to assess the incidence of underdosing and the pharmacokinetics of piperacillin in critically ill patients with OA/NPT.
The secondary objective was to assess the appropriateness of recommended regimens for empirical minimum inhibitory concentration (MIC) coverage.
- Being tested
- Blood sampling (T0, inclusion), other samplings (T1)
- Keywords
- Open Abdomen, Negative Pressure Therapy, Antibiotics, Piperacillin - Tazobactam, Pharmacokinetics
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling (T0, inclusion)Procedure or surgery
Blood sample (5 ml) at 30 minutes after the loading dose of 4g/0.5g over 30 minutes for therapeutic drug monitoring at peak concentration (Cmax)
other samplings (T1)Procedure or surgery
- T1 : Day of the first surgical revision, under PTZ administered by continuous infusion : Blood sample (5 ml) for therapeutic drug monitoring at steady state concentration (Css).
Urinary sample and collection of urinary volume between T0 and T1 (Urinary Clearance) NPT fluid sample and collection of NPT volume between T0 and T1 (Peritoneal Clearance) Peritoneal sampling for therapeutic drug monitoring at the site of infection (CPt)
| Study group | Role | What they receive |
|---|---|---|
| Participant | Critically Ill Patients with Open Abdomen and Negative Pressure Wound Therapy Receives: Procedure: Blood sampling (T0, inclusion); Procedure: other samplings (T1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of piperacillin
The main outcome investigated in this study was the rate of piperacillin (PIP) underdosing, arbitrarily defined by at least one of three samples under 16 mg/L. This threshold represents the highest MIC for Pseudomonas as per the European Committee on Antimicrobial Susceptibility Testing (EUCAST).
Measured: T1 (Day of the first surgical revision, up to 72 hours after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Jul 2021
- Primary completion18 Nov 2022
- Study completion27 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparotomyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915872
- Sponsor's protocol ID
- CHUBX 2020/53
- Acronym
- PK-LAP
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2021
- Last updated
- 27 Feb 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 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Standard Dosing Regimens of Piperacillin-Tazobactam Suitable in Critically Ill Patients With Open Abdomen and Negative Pressure Wound Therapy? A Population Pharmacokinetic Study.
- ClinicalTrials.gov ID
- NCT04915872
- Acronym / sponsor ID
- PK-LAP / CHUBX 2020/53
- Keywords
- Open Abdomen, Negative Pressure Therapy, Antibiotics, Piperacillin - Tazobactam, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 7 Jun 2021 (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.
For several years, open abdomen with temporary abdominal closure using Negative Pressure Therapy (OA/NPT) has become one of the leading strategies to treat or prevent intra-abdominal hypertension in critically ill surgical patients after a wide range of complex abdominal injuries and conditions.
According to current practice, piperacillin-tazobactam (PTZ) is widely used as part of empirical combined antibiotic therapy to treat severe abdominal infections in the critically ill patients. On the other hand, little is known about the impact of OA/NPT on antibiotics pharmacokinetics and pharmacodynamics (PK/PD) and the optimal dosing regimens in this population remain unclear.
As PTZ is a small hydrophilic molecule with a very low level of protein binding, invesitigators hypothesized that OA/NPT should lead to significant changes in volume of distribution (Vd) and/or drug clearance (CL
The main objective of this study was to assess the incidence of underdosing and the pharmacokinetics of piperacillin in critically ill patients with OA/NPT.
The secondary objective was to assess the appropriateness of recommended regimens for empirical minimum inhibitory concentration (MIC) coverage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant | – | Procedure: Blood sampling (T0, inclusion), Procedure: other samplings (T1)Critically Ill Patients with Open Abdomen and Negative Pressure Wound Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically Ill Patients with Open Abdomen and Negative Pressure Wound Therapy
Key inclusion criteria (6 listed)
- Age ≥ 18
- Admitted in surgical ICU for a suspected length of stay > 3 days
- Receiving an antimicrobial therapy by PTZ
- For an intra-abdominal infection
- Under OA/NPT during antimicrobial therapy
Key exclusion criteria (5 listed)
- Severe renal failure (CLCR < 30 ml/min) without indication for continuous renal replacement therapy (CRRT)
- Known allergy to PTZ
- Patient's refusal for participation to the research
- Patient unable to consent (dementia or severe psychiatric disorders, people under legal protection, people deprived of their liberty...)
- Pregnancy or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling (T0, inclusion)Blood sample (5 ml) at 30 minutes after the loading dose of 4g/0.5g over 30 minutes for therapeutic drug monitoring at peak concentration (Cmax) | Procedure or surgery | Participant |
| other samplings (T1)- T1 : Day of the first surgical revision, under PTZ administered by continuous infusion : Blood sample (5 ml) for therapeutic drug monitoring at steady state concentration (Css). Urinary sample and collection of urinary volume between T0 and T1 (Urinary Clearance) NPT fluid sample and collection of NPT volume between T0 and T1 (Peritoneal Clearance) Peritoneal sampling for therapeutic drug monitoring at the site of infection (CPt) | Procedure or surgery | Participant |
Primary outcome
Rate of piperacillin
Time frame: T1 (Day of the first surgical revision, up to 72 hours after inclusion)
The main outcome investigated in this study was the rate of piperacillin (PIP) underdosing, arbitrarily defined by at least one of three samples under 16 mg/L. This threshold represents the highest MIC for Pseudomonas as per the European Committee on Antimicrobial Susceptibility Testing (EUCAST).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Laparotomy and Critical Illness, run by University Hospital, Bordeaux at 1 site in France.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 27 Feb 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of piperacillin (time frame: T1 (Day of the first surgical revision, up to 72 hours after inclusion)). 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 27 Feb 2023.