Viewing Study NCT01152502


Ignite Creation Date: 2025-12-25 @ 3:47 AM
Ignite Modification Date: 2025-12-26 @ 2:34 AM
Study NCT ID: NCT01152502
Status: COMPLETED
Last Update Posted: 2010-06-29
First Post: 2010-06-28
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Paracetamol Metabolism in Post Operative Conditions
Sponsor: University Hospital, Clermont-Ferrand
Organization:

Study Overview

Official Title: Paracetamol Metabolism in Post Operative Conditions
Status: COMPLETED
Status Verified Date: 2010-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Follow-up of urinary concentration from paracetamol metabolites by patients with aortic surgery during 4 days therapeutic intake (perfalgan ® 4 x 1g IV/day)
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 Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: