Paracetamol Metabolism in Post Operative Conditions

June 28, 2010 updated by: University Hospital, Clermont-Ferrand
Follow-up of urinary concentration from paracetamol metabolites by patients with aortic surgery during 4 days therapeutic intake (perfalgan ® 4 x 1g IV/day)

Study Overview

Status

Completed

Conditions

Detailed Description

D-15 to D0: selection

  • patient information and non-opposition obtained
  • inclusion and non inclusion criteria check
  • clinical exam

D-1 to D0 : 24 hours diuresis

D0 : operation day

Before anesthesia :

  • urine collection (paracetamol metabolites dosage)
  • blood sampling (glutathion and liver function test)

Surgery:

  • 1st paracetamol intake before closing
  • Then administration every 6 hours

D1 to D4 :

  • 24 hours urine collection (metabolites dosage)
  • blood sampling et D1 and D4(glutathion and liver function test)

D5 : final clinical exam

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

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

Defined population

Description

Inclusion Criteria:

  • aortic surgery
  • treatment with intraveinous paracetamol (4 grammes daily during 4 days)
  • patient agrees to participate

Exclusion Criteria:

  • - patient disagrees
  • paracetamol contra-indication
  • paracetamol intake 5 days before surgery

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
Follow-up of urinary concentration from paracetamol metabolites by patients with aortic surgery during 4 days therapeutic intake (perfalgan ® 4 x 1g IV/day)
Time Frame: during 4 days therapeutic intake
during 4 days therapeutic intake

Secondary Outcome Measures

Outcome Measure
Time Frame
- Follow-up of glutathion concentration during 4 post operative days
Time Frame: during 4 post operative days
during 4 post operative days
Monitoring of liver function

Collaborators and Investigators

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

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Eric SCHNEIDER, University Hospital, Clermont-Ferrand

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

June 1, 2008

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

June 28, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (ESTIMATE)

June 29, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 29, 2010

Last Update Submitted That Met QC Criteria

June 28, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0076

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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