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OpenTrials
Completed

NCT Number: NCT01152502

Paracetamol Metabolism in Post Operative Conditions

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. - Follow-up of glutathion concentration during 4 post operative days

    Time frame: during 4 post operative days

  2. Monitoring of liver function

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2010
First posted
Jun 29, 2010
Registry last updated
Jun 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.