Cardiac Surgery Requiring Cardiopulmonary BypassNCT07087301
Vancomycin Concentration Analysis in Post-Cardiac Surgery Patients
An observational study of Cardiac Surgery Requiring Cardiopulmonary Bypass, run by Pengqiang Du at 1 site in China.
Trial summary
The benefits of antimicrobial prophylaxis for cardiac surgery have been clearly demonstrated in placebo-controlled studies. Prophylactic intravenous antibiotics are therefore administered, with agent selection directed against the most common skin-colonising and gram-negative bacteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery Requiring Cardiopulmonary Bypass
- What is being tested?
- subtherapeutic concentration risk group
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2024
- 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: Patients requiring cardiac surgery for conditions such as valvular heart disease who received postoperative vancomycin for infections.
Who may be able to join
- Undergoing cardiac surgery with cardiopulmonary bypass
- Received intravenous vancomycin postoperatively for infection prophylaxis or treatment
Who cannot join
- Age <18 years
- Missing data on weight, height, or serum creatinine during vancomycin therapy
- No vancomycin trough plasma concentration recorded
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 450046
About this study
Official title: A Prospective Observational Study to Analyze Factors Influencing Vancomycin Blood Concentrations in Post-Cardiac Surgery Patients Under Extracorporeal Circulation
The benefits of antimicrobial prophylaxis for cardiac surgery have been clearly demonstrated in placebo-controlled studies. Prophylactic intravenous antibiotics are therefore administered, with agent selection directed against the most common skin-colonising and gram-negative bacteria. Controversy persists regarding the optimal antimicrobial choice and duration of administration for cardiac surgery. In settings with a high incidence of methicillin-resistant Staphylococcus aureus (MRSA), administration of cefazolin or vancomycin for prophylaxis is considered reasonable (Class IIB recommendation, Level of Evidence C).
Vancomycin, a glycopeptide antibiotic, is widely used to treat serious gram-positive infections, including those caused by MRSA and methicillin-resistant Staphylococcus epidermidis (MRSE). Extensive pharmacokinetic/pharmacodynamic (PK/PD) studies reveal marked variability in population PK parameters across patient groups; clearance variability may reach 45 % and volume of distribution variability 48 %.
Read more
Oral vancomycin absorption is poor (≈5 % bioavailability), yet luminal concentrations remain sufficiently high for efficacy against Clostridioides difficile-associated pseudomembranous colitis. Inter-individual PK variability is substantial; two- or three-compartment models are typically employed. Protein binding ranges from 30 % to 50 %. Approximately 90 % of the dose is eliminated unchanged via the kidneys; biliary elimination is minimal. The elimination half-life is 4-7 h in individuals with normal renal function and is prolonged in patients >65 years or with renal impairment. Obesity, age, renal function, concomitant medications, disease state, and peri-operative interventions can all influence vancomycin clearance and apparent volume of distribution, potentially yielding sub- or supra-therapeutic serum concentrations.
To characterise current therapeutic drug monitoring (TDM) practices for vancomycin in cardiac-surgery patients undergoing cardiopulmonary bypass, this retrospective study combined multimodal data to develop a prognostic model predicting high- or low-risk vancomycin serum levels post-operatively. Model performance was evaluated to provide an evidence base for individualised dosing strategies aimed at optimising efficacy and minimising adverse effects.
Pharmacokinetic datasets from post-cardiac-surgery patients receiving cardiopulmonary bypass were analysed to identify determinants of vancomycin blood concentrations. Integration of baseline characteristics and medication records supports early intervention guidance for individualised vancomycin dosing and optimisation of anti-infective therapy.
- Being tested
- subtherapeutic concentration risk group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subtherapeutic concentration risk groupOther
The second model (for subtherapeutic concentration risk prediction) defined low concentration as trough <10 mg/L and target as 10-20 mg/L to analyze predictors of target concentration attainment.
subtherapeutic concentration risk groupDrug
The second model (for subtherapeutic concentration risk prediction) defined low concentration as trough <10 mg/L and target as 10-20 mg/L to analyze predictors of target concentration attainment.
| Study group | Role | What they receive |
|---|---|---|
| nephrotoxicity risk group | nephrotoxicity risk group (≥20 mg/L vs <20 mg/L, n=350). A dual-model framework was established based on vancomycin's therapeutic window (10-20 mg/L): the first model (for nephrotoxicity risk prediction) defined high concentration as ≥20 mg/L and control as <20 mg/L to identify risk factors for vancomycin accumulation. Receives: Other: subtherapeutic concentration risk group; Drug: subtherapeutic concentration risk group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vancomycin trough concentration
Pre-dose vancomycin serum concentration at steady state
Measured: Day 3 pre-dose
Secondary outcomes (2)
Cardiopulmonary Bypass Duration
Duration of cardiopulmonary bypass during cardiac surgery, recorded from initiation to termination.
Measured: Intra-operative (from initiation to termination of bypass)
Creatinine Clearance
Calculated using Cockcroft-Gault equation
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery Requiring Cardiopulmonary BypassStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pengqiang Du
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pengqiang Du, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087301
- Sponsor's protocol ID
- 2023-Ethics79
- Status last verified
- Dec 2024
- First submitted
- 8 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- 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 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Analyze Factors Influencing Vancomycin Blood Concentrations in Post-Cardiac Surgery Patients Under Extracorporeal Circulation
- ClinicalTrials.gov ID
- NCT07087301
- Acronym / sponsor ID
- 2023-Ethics79
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Pengqiang DuUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 Jul 2025 (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.
The benefits of antimicrobial prophylaxis for cardiac surgery have been clearly demonstrated in placebo-controlled studies. Prophylactic intravenous antibiotics are therefore administered, with agent selection directed against the most common skin-colonising and gram-negative bacteria. Controversy persists regarding the optimal antimicrobial choice and duration of administration for cardiac surgery. In settings with a high incidence of methicillin-resistant Staphylococcus aureus (MRSA), administration of cefazolin or vancomycin for prophylaxis is considered reasonable (Class IIB recommendation, Level of Evidence C).
Vancomycin, a glycopeptide antibiotic, is widely used to treat serious gram-positive infections, including those caused by MRSA and methicillin-resistant Staphylococcus epidermidis (MRSE). Extensive pharmacokinetic/pharmacodynamic (PK/PD) studies reveal marked variability in population PK parameters across patient groups; clearance variability may reach 45 % and volume of distribution variability 48 %.
Oral vancomycin absorption is poor (≈5 % bioavailability), yet luminal concentrations remain sufficiently high for efficacy against Clostridioides difficile-associated pseudomembranous colitis. Inter-individual PK variability is substantial; two- or three-compartment models are typically employed. Protein binding ranges from 30 % to 50 %. Approximately 90 % of the dose is eliminated unchanged via the kidneys; biliary elimination is minimal. The elimination half-life is 4-7 h in individuals with normal renal function and is prolonged in patients >65 years or with renal impairment. Obesity, age, renal function, concomitant medications, disease state, and peri-operative interventions can all influence vancomycin clearance and apparent volume of distribution, potentially yielding sub- or supra-therapeutic serum concentrations.
To characterise current therapeutic drug monitoring (TDM) practices for vancomycin in cardiac-surgery patients undergoing cardiopulmonary bypass, this retrospective study combined multimodal data to develop a prognostic model predicting high- or low-risk vancomycin serum levels post-operatively. Model performance was evaluated to provide an evidence base for individualised dosing strategies aimed at optimising efficacy and minimising adverse effects.
Pharmacokinetic datasets from post-cardiac-surgery patients receiving cardiopulmonary bypass were analysed to identify determinants of vancomycin blood concentrations. Integration of baseline characteristics and medication records supports early intervention guidance for individualised vancomycin dosing and optimisation of anti-infective therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nephrotoxicity risk group | – | Other: subtherapeutic concentration risk group, Drug: subtherapeutic concentration risk groupnephrotoxicity risk group (≥20 mg/L vs <20 mg/L, n=350). A dual-model framework was established based on vancomycin's therapeutic window (10-20 mg/L): the first model (for nephrotoxicity risk prediction) defined high concentration as ≥20 mg/L and control as <20 mg/L to identify risk factors for vancomycin accumulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring cardiac surgery for conditions such as valvular heart disease who received postoperative vancomycin for infections.
Key inclusion criteria (2 listed)
- Undergoing cardiac surgery with cardiopulmonary bypass
- Received intravenous vancomycin postoperatively for infection prophylaxis or treatment
Key exclusion criteria (3 listed)
- Age <18 years
- Missing data on weight, height, or serum creatinine during vancomycin therapy
- No vancomycin trough plasma concentration recorded
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 |
|---|---|---|
| subtherapeutic concentration risk groupThe second model (for subtherapeutic concentration risk prediction) defined low concentration as trough <10 mg/L and target as 10-20 mg/L to analyze predictors of target concentration attainment. | Other | nephrotoxicity risk group |
| subtherapeutic concentration risk groupThe second model (for subtherapeutic concentration risk prediction) defined low concentration as trough <10 mg/L and target as 10-20 mg/L to analyze predictors of target concentration attainment. | Drug | nephrotoxicity risk group |
Primary outcome
Vancomycin trough concentration
Time frame: Day 3 pre-dose
Pre-dose vancomycin serum concentration at steady state
2 secondary outcomes
Cardiopulmonary Bypass Duration
Time frame: Intra-operative (from initiation to termination of bypass)
Creatinine Clearance
Time frame: Baseline
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 25 Jul 2025.
- 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 Cardiac Surgery Requiring Cardiopulmonary Bypass, run by Pengqiang Du 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 2 inclusion and 3 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 25 Jul 2025. 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?
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?
Vancomycin trough concentration (time frame: Day 3 pre-dose). 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 25 Jul 2025.