Trial record 2 of 12 for:    ACETAMINOPHEN METABOLISM

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on October 19, 2014