Paracetamol Metabolism in Post Operative Conditions

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01152502
First received: June 28, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01152502     History of Changes
Other Study ID Numbers: CHU-0076
Study First Received: June 28, 2010
Last Updated: June 28, 2010
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on April 17, 2014