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

NCT ID: NCT02134665

Last Updated: 2014-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-05-31

Brief Summary

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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

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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.

Conditions

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Arbitrary Restriction Polymorphism 1

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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severe acute pancreatitis

patients who received vancomycin therapy and whose serum vancomycin level was monitored, and who also had diagnosed as severe acute pancreatitis.

No interventions assigned to this group

Pneumonia

patients who received vancomycin therapy and whose serum vancomycin level was monitored, and who also had diagnosed as pneumonia.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* age \<18years old or \>85 years old
* vancomycin use \< 3days
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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He Juan

Miss

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wan-Hua Yang, Prof.

Role: STUDY_DIRECTOR

Ruijin Hospital

Locations

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Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Juan He

Role: CONTACT

86-21-64370045 ext. 664405

Facility Contacts

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He

Role: primary

86-21-64370045 ext. 662618

Other Identifiers

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hejuanwin19811119

Identifier Type: -

Identifier Source: org_study_id

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