Paracetamol Metabolism in Post Operative Conditions | NCT01152502

Studies
Paracetamol Metabolism in Post Operative Conditions

NCT01152502

Sponsor

University Hospital, Clermont-Ferrand

Status

Completed

Last Update Posted

Jun 29, 2010Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Aortic Surgery and Treatment Post Operative With Paracetamol During 4 Days

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Sep 2008Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jun 28, 2010

First Submission Date that Met QC Criteria

Jun 28, 2010

First Posted Date

Jun 29, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2010

Last Update Posted Date

Jun 29, 2010Estimated

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
- Follow-up of glutathion concentration during 4 post operative days		during 4 post operative days
Monitoring of liver function

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Defined population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric SCHNEIDER	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Clermont-Ferrand		Clermont-Ferrand		63003	France