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Paracetamol Metabolism in Post Operative Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01152502
First Posted: June 29, 2010
Last Update Posted: June 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Clermont-Ferrand
  Purpose
Follow-up of urinary concentration from paracetamol metabolites by patients with aortic surgery during 4 days therapeutic intake (perfalgan ® 4 x 1g IV/day)

Condition
Aortic Surgery and Treatment Post Operative With Paracetamol During 4 Days

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Paracetamol Metabolism in Post Operative Conditions

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • - Follow-up of glutathion concentration during 4 post operative days [ Time Frame: during 4 post operative days ]
  • Monitoring of liver function

Enrollment: 30
Study Start Date: June 2008
Study Completion Date: June 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Defined population
Criteria

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
  Contacts and Locations
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): NCT01152502


Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Eric SCHNEIDER University Hospital, Clermont-Ferrand
  More Information

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01152502     History of Changes
Other Study ID Numbers: CHU-0076
First Submitted: June 28, 2010
First Posted: June 29, 2010
Last Update Posted: June 29, 2010
Last Verified: June 2010

Keywords provided by University Hospital, Clermont-Ferrand:
Post operative conditions, paracetamol metabolites

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics