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NCT Number: NCT07087301

Vancomycin Concentration Analysis in Post-Cardiac Surgery Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, 450046, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

subtherapeutic concentration risk group

Other

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 group

Drug

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.

Primary outcomes

  1. Vancomycin trough concentration

    Time frame: Day 3 pre-dose

    Pre-dose vancomycin serum concentration at steady state

Secondary outcomes

  1. Cardiopulmonary Bypass Duration

    Time frame: Intra-operative (from initiation to termination of bypass)

    Duration of cardiopulmonary bypass during cardiac surgery, recorded from initiation to termination.

  2. Creatinine Clearance

    Time frame: Baseline

    Calculated using Cockcroft-Gault equation

Sponsors and collaborators

Lead sponsor

Pengqiang Du

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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