Liver Transplant InfectionProCeTHNCT04280237
Pharmacological Study of Cefazolin Antibioprophylaxis in Liver Transplantation
An observational study of Liver Transplant Infection and Surgical Site Infection, run by University Hospital, Tours at 1 site in France.
Trial summary
This study describes Cefazolin pharmacokinetics variation to target levels during liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Infection, Surgical Site Infection, Antibiotic Prophylaxis
- What is being tested?
- Blood samples
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2020to 18 Mar 2020
- 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: All patient receiving Cefazolin as perioperative antibiotic prophylaxis during liver transplantation.
Who may be able to join
- Age over 18
- patient undergoing liver transplantation
- receiving Cefazolin as perioperative antibiotic prophylaxis to prevent surgical site infections
Who cannot join
- pregnant women
- legal protection or protected adults
- ongoing antibiotic treatment before liver transplantation
- patient inability to receive information or express opposition to the study.
- patient refusing participation
Trial locations and contacts
1 site in 1 country.
France1 site
Surgical intensive care unit, University Hospital, Tours
Tours, 37044
About this study
This study describes Cefazolin pharmacokinetics variation to target levels during liver transplantation.
Read the detailed description
Cefazolin is one of the many drugs used in antibiotic prophylaxis during liver transplantation. However there are no study describing its pharmacokinetics during liver transplantation.
Due to the severe pharmacokinetics interactions caused by both prior hepatopathy and surgical techniques we suppose that Cefazolin blood levels are very different from those targeted for antibiotic prophylaxis.
This study aim to describe pharmacokinetics of Cefazolin during liver transplantation in order to adapt antibiotic prophylaxis strategy in case of unadapted measured levels.
- Conditions
- Liver Transplant Infection, Surgical Site Infection, Antibiotic Prophylaxis, Cephazolin Adverse Reaction
- Being tested
- Blood samples
- Keywords
- antibiotic prophylaxis, liver transplant, surgical site infection, Cefazolin
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Blood samples
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin in liver transplantation | Patient undergoing liver transplant surgery and receiving antibiotic prophylaxis with Cefazolin Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cefazolin blood concentration
Cefazolin blood concentration will be measured at the moment of surgical incision and every hour until end of surgery
Measured: Baseline up to 10 hours
Secondary outcomes (22)
Assess correlations between Cefazolin blood concentration and CHILD-PUGH score
Patient's CHILD-PUGH score before transplantation
Measured: baseline
Assess correlations between Cefazolin blood concentration and MELD score
Patient's MELD score before transplantation
Measured: baseline
Assess correlations between Cefazolin blood concentration and Cirrhosis etiology
Cause of cirrhosis
Measured: baseline
Assess correlations between Cefazolin blood concentration and Transplantation indication
Cause leading to transplantation
Measured: baseline
Assess correlations between Cefazolin blood concentration and Transjugular intrahepatic portosystemic shunt (TIPS)
Medical history of TIPS
Measured: baseline
Assess correlations between Cefazolin blood concentration and Creatinine
Creatinine levels will be measured before transplantation
Measured: baseline
Assess correlations between Cefazolin blood concentration and Hemodialysis
Patient needing hemodialysis before liver transplantation
Measured: baseline
Assess correlations between Cefazolin blood concentration and Albumin
Albumin levels will be measured before transplantation
Measured: baseline
Assess correlations between Cefazolin blood concentration and Surgery duration
Time of surgical incision and end of the surgery will be noted
Measured: End of surgery
Assess correlations between Cefazolin blood concentration and Portal vein clamping time
Time of portal vein clamping and declamping during realization of vascular anastomosis will be noted
Measured: End of surgery
Assess correlations between Cefazolin blood concentration and Ascitis
Volume of ascitis drained at the beginning of surgery
Measured: Baseline
Assess correlations between Cefazolin blood concentration and Urine output
Volume of urine output during surgery
Measured: End of surgery
Assess correlations between Cefazolin blood concentration and Blood loss
Blood loss quantification will be done throughout surgery
Measured: End of surgery
Assess correlations between Cefazolin blood concentration and Red cell transfusion unit
The number of red cell units transfused during transplantation will be counted at the end of surgery
Measured: End of surgery
Assess correlations between Cefazolin blood concentration and Platelet transfusion unit
The number of platelet units transfused during transplantation will be counted at the end of surgery
Measured: End of surgery
Assess correlations between Cefazolin blood concentration and Plasma transfusion unit
The number of plasma units transfused during transplantation will be counted at the end of surgery
Measured: End of surgery
Assess correlations between Cefazolin blood concentration and Intraoperative blood salvage
Intraoperative blood salvage transfusion volume during surgery
Measured: End of surgery
Assess correlations between Cefazolin blood concentration and Crystalloid infusion
Assess correlations between Cefazolin blood concentration and Volume of crystalloid infusion during surgery
Measured: End of surgery
Assess correlations between Cefazolin blood concentration and Colloid infusion
Volume of colloid infusion during surgery
Measured: End of surgery
Assess correlations between Cefazolin blood concentration and Basal cardiac index
Cardiac index value at the beginning of surgery
Measured: Baseline
Assess correlations between Cefazolin blood concentration and Minimal cardiac index
Minimal index value during surgery
Measured: End of surgery
Assess correlations between Cefazolin blood concentration and Surgical site infection
Number of patient with surgical site infection in the 28 days post-surgery
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study startMar 2020 (estimated)
- Primary completion18 Mar 2020
- Study completion18 Mar 2020
Why it stopped: abandoned project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Charlotte TELLIER, MD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280237
- Sponsor's protocol ID
- RIPH3-RNI20/ProCeTH
- Other IDs
- 2020-A00405-34
- Acronym
- ProCeTH
- Status last verified
- Apr 2021
- First submitted
- 18 Feb 2020
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Study of Cefazolin Antibioprophylaxis in Liver Transplantation
- ClinicalTrials.gov ID
- NCT04280237
- Acronym / sponsor ID
- ProCeTH / RIPH3-RNI20/ProCeTH
- Conditions
- Liver Transplant Infection, Surgical Site Infection, Antibiotic Prophylaxis, Cephazolin Adverse Reaction
- Keywords
- antibiotic prophylaxis, liver transplant, surgical site infection, Cefazolin
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: abandoned project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 21 Feb 2020 (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 describes Cefazolin pharmacokinetics variation to target levels during liver transplantation.
Detailed description
Cefazolin is one of the many drugs used in antibiotic prophylaxis during liver transplantation. However there are no study describing its pharmacokinetics during liver transplantation.
Due to the severe pharmacokinetics interactions caused by both prior hepatopathy and surgical techniques we suppose that Cefazolin blood levels are very different from those targeted for antibiotic prophylaxis.
This study aim to describe pharmacokinetics of Cefazolin during liver transplantation in order to adapt antibiotic prophylaxis strategy in case of unadapted measured levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cefazolin in liver transplantation | – | Other: Blood samplesPatient undergoing liver transplant surgery and receiving antibiotic prophylaxis with Cefazolin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patient receiving Cefazolin as perioperative antibiotic prophylaxis during liver transplantation.
Key inclusion criteria (3 listed)
- Age over 18
- patient undergoing liver transplantation
- receiving Cefazolin as perioperative antibiotic prophylaxis to prevent surgical site infections
Key exclusion criteria (5 listed)
- pregnant women
- legal protection or protected adults
- ongoing antibiotic treatment before liver transplantation
- patient inability to receive information or express opposition to the study.
- patient refusing participation
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 samplesBlood samples | Other | Cefazolin in liver transplantation |
Primary outcome
Cefazolin blood concentration
Time frame: Baseline up to 10 hours
Cefazolin blood concentration will be measured at the moment of surgical incision and every hour until end of surgery
22 secondary outcomes
Assess correlations between Cefazolin blood concentration and CHILD-PUGH score
Time frame: baseline
Assess correlations between Cefazolin blood concentration and MELD score
Time frame: baseline
Assess correlations between Cefazolin blood concentration and Cirrhosis etiology
Time frame: baseline
Assess correlations between Cefazolin blood concentration and Transplantation indication
Time frame: baseline
Assess correlations between Cefazolin blood concentration and Transjugular intrahepatic portosystemic shunt (TIPS)
Time frame: baseline
Assess correlations between Cefazolin blood concentration and Creatinine
Time frame: baseline
Assess correlations between Cefazolin blood concentration and Hemodialysis
Time frame: baseline
Assess correlations between Cefazolin blood concentration and Albumin
Time frame: baseline
Assess correlations between Cefazolin blood concentration and Surgery duration
Time frame: End of surgery
Assess correlations between Cefazolin blood concentration and Portal vein clamping time
Time frame: End of surgery
Assess correlations between Cefazolin blood concentration and Ascitis
Time frame: Baseline
Assess correlations between Cefazolin blood concentration and Urine output
Time frame: End of surgery
Assess correlations between Cefazolin blood concentration and Blood loss
Time frame: End of surgery
Assess correlations between Cefazolin blood concentration and Red cell transfusion unit
Time frame: End of surgery
Assess correlations between Cefazolin blood concentration and Platelet transfusion unit
Time frame: End of surgery
Assess correlations between Cefazolin blood concentration and Plasma transfusion unit
Time frame: End of surgery
Assess correlations between Cefazolin blood concentration and Intraoperative blood salvage
Time frame: End of surgery
Assess correlations between Cefazolin blood concentration and Crystalloid infusion
Time frame: End of surgery
Assess correlations between Cefazolin blood concentration and Colloid infusion
Time frame: End of surgery
Assess correlations between Cefazolin blood concentration and Basal cardiac index
Time frame: Baseline
Assess correlations between Cefazolin blood concentration and Minimal cardiac index
Time frame: End of surgery
Assess correlations between Cefazolin blood concentration and Surgical site infection
Time frame: Day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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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.
Anne-Charlotte TELLIER, MD principal investigator
University Hospital, Tours
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 Liver Transplant Infection and Surgical Site Infection, run by University Hospital, Tours 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 3 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: withdrawn, as of the sponsor's last update on 29 Apr 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Cefazolin blood concentration (time frame: Baseline up to 10 hours). 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 29 Apr 2021.