Unexpected Pharmacokinetics of Vancomycin in Patients With Severe Acute Pancreatitis Compared With Pneumonia

• Conditions: Arbitrary Restriction Polymorphism 1

• Registration Number: NCT02134665
• Lead Sponsor: Ruijin Hospital

Brief Summary

The purpose of this study was to evaluate the influence of severe acute pancreatitis on the serum level of vancomycin, a glycopeptide antibacterial agent.

Detailed Description

The purpose of this study was to evaluate the influence of severe acute pancreatitis on the serum level of vancomycin, a glycopeptide antibacterial agent.

After reviewing more than 6000 clinical charts of patients who received vancomycin therapy and whose serum vancomycin level was monitored between January 2010 and December 2013, we identified 212 patients who also had diagnosed as severe acute pancreatitis (SAP group), and 98 patients who also had diagnosed as pneumonia (pneumonia group) at that time. The fluorescence polarization immunoassay method was used to measure vancomycin serum trough concentrations in these patients 30 min before the next administration. Using these measurements, we calculated the pharmacokinetic parameters using the Bayesian estimator.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2014-01-24
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted QC: 2014-05-07
• Last Update Submitted: 2014-05-07
• Study First Posted: 2014-05-09
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• age 18-85years old
• vancomycin use ≥ 3days

Exclusion Criteria

• age <18years old or >85 years old
• vancomycin use < 3days

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
vancomycin serum trough concentrations in these patients just prior to the next vancomycin serum trough concentrations was measured	patients will be followed for the duration of hospital stay, an expected average of 5 weeks	vancomycin serum trough concentrations was measured in patients just prior to the next dose at steady-state conditions (approximately after the fourth dose).

Secondary Outcome Measures

Name	Time	Method
the pharmacokinetic parameters was calculated using the Bayesian estimator.	patients will be followed for the duration of hospital stay, an expected average of 5 weeks

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China