Assessment of International Normalized Ratio (INR) Prolongation in Patients Treated Simultaneously With Warfarin and Cephalosporins

Atrial Fibrillation Clinical Trial

Official title:

Assessment of INR Prolongation in Patients Treated Simultaneously With Warfarin and Antibiotics From the Cephalosporins Family,Observational Retrospective Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857050
• Other study ID #: MMC130210-12CTIL
• Status: Completed
• Phase: N/A
• First received: May 16, 2013
• Last updated: February 24, 2014
• Start date: April 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Many drug interactions with Warfarin are well documented in the literature, including interactions with a variety of antibiotics. However,in mamy cases it is difficult to predict when the interaction remains theoretical and when it becomes clinically significant and will be reflected in the individual patient. This study's aim is to identify and characterize related conditions (including comorbidities, laboratory test results and other parameters related to the patient)that might be predictors for drug interactions turning from theoretical to clinically significant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 18 and over

• Patients treated with a combination of Warfarin and Cephalosporins

• Patients who were hospitalized in the department of internal medicine

• Patients who were treated with Warfarin without Cefalosporins

Exclusion Criteria:

• Patients on Warfarin who did not actually receive the drug during their hospitalization

• Patients whose medical records were not accessible or didn't contain full data

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Pulmonary Embolism
• Venous Thrombosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reasons for INR prolongation in patients who were treated with the combination of Warfarin and Cephalosporins		Participants will be followed for the duration of thei hospital stay, an expected average of 7 days	Yes