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

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ClinicalTrials.gov Identifier: NCT02134665
Recruitment Status : Unknown
Verified May 2014 by He Juan, Ruijin Hospital.
Recruitment status was:  Recruiting
First Posted : May 9, 2014
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
He Juan, 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.

Condition or disease
Arbitrary Restriction Polymorphism 1

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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Unexpected Pharmacokinetics of Vancomycin in Patients With Severe Acute Pancreatitis Compared With Pneumonia
Study Start Date : May 2013
Actual Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

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



Primary Outcome Measures :
  1. vancomycin serum trough concentrations in these patients just prior to the next vancomycin serum trough concentrations was measured [ Time Frame: 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 :
  1. the pharmacokinetic parameters was calculated using the Bayesian estimator. [ Time Frame: patients will be followed for the duration of hospital stay, an expected average of 5 weeks ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients who used vancomycin and who had diagnosed as severe acute pancreatitis (SAP group), and patients who had diagnosed as pneumonia (pneumonia group) . meanwhile, the fluorescence polarization immunoassay method was used to measure vancomycin serum trough concentrations in these patients 30 min before the next administration.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134665


Contacts
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Contact: Juan He 86-21-64370045 ext 664405 hejuanwin@126.com

Locations
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China, Shanghai
Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: He    86-21-64370045 ext 662618      
Sponsors and Collaborators
Ruijin Hospital
Investigators
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Study Director: Wan-Hua Yang, Prof. Ruijin Hospital

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Responsible Party: He Juan, Miss, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02134665     History of Changes
Other Study ID Numbers: hejuanwin19811119
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014
Keywords provided by He Juan, Ruijin Hospital:
Vancomycin
severe acute pancreatitis
Creatinine clearance
Additional relevant MeSH terms:
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Pancreatitis
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pancreatic Diseases
Digestive System Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents