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Vancomycin Concentration Analysis in Post-Cardiac Surgery Patients

A Prospective Observational Study to Analyze Factors Influencing Vancomycin Blood Concentrations in Post-Cardiac Surgery Patients Under Extracorporeal Circulation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07087301
Enrollment
350
Registered
2025-07-25
Start date
2023-01-01
Completion date
2024-12-31
Last updated
2025-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery Requiring Cardiopulmonary Bypass

Brief 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. 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.

Interventions

OTHERsubtherapeutic concentration risk group

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.

Sponsors

Pengqiang Du
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Undergoing cardiac surgery with cardiopulmonary bypass * Received intravenous vancomycin postoperatively for infection prophylaxis or treatment

Exclusion criteria

* Age \<18 years * Missing data on weight, height, or serum creatinine during vancomycin therapy * No vancomycin trough plasma concentration recorded

Design outcomes

Primary

MeasureTime frameDescription
Vancomycin trough concentrationDay 3 pre-dosePre-dose vancomycin serum concentration at steady state

Secondary

MeasureTime frameDescription
Cardiopulmonary Bypass DurationIntra-operative (from initiation to termination of bypass)Duration of cardiopulmonary bypass during cardiac surgery, recorded from initiation to termination.
Creatinine ClearanceBaselineCalculated using Cockcroft-Gault equation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026