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

February 24, 2014 updated by: Meir Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

236

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Warfarin-treated patients who were hospitalized for any reason in the department of internal medicine and were treated with antibiotics from the Cephalosporins group during their hospitalization.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reasons for INR prolongation in patients who were treated with the combination of Warfarin and Cephalosporins
Time Frame: Participants will be followed for the duration of thei hospital stay, an expected average of 7 days
Participants will be followed for the duration of thei hospital stay, an expected average of 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Michael Lishner, MD, Meir Hospital, Kfar Saba, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

May 16, 2013

First Submitted That Met QC Criteria

May 17, 2013

First Posted (ESTIMATE)

May 20, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 25, 2014

Last Update Submitted That Met QC Criteria

February 24, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC130210-12CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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