Aortic Surgery and Treatment Post Operative With Paracetamol During 4 DaysNCT01152502
Paracetamol Metabolism in Post Operative Conditions
An observational study of Aortic Surgery and Treatment Post Operative With Paracetamol During 4 Days, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Surgery and Treatment Post Operative With Paracetamol During 4 Days
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Defined population
Who may be able to join
- aortic surgery
- treatment with intraveinous paracetamol (4 grammes daily during 4 days)
- patient agrees to participate
Who cannot join
- - patient disagrees
- paracetamol contra-indication
- paracetamol intake 5 days before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Follow-up of urinary concentration from paracetamol metabolites by patients with aortic surgery during 4 days therapeutic intake (perfalgan ® 4 x 1g IV/day)
Read the 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
- Keywords
- Post operative conditions, paracetamol metabolites
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow-up of urinary concentration from paracetamol metabolites by patients with aortic surgery during 4 days therapeutic intake (perfalgan ® 4 x 1g IV/day)
Measured: during 4 days therapeutic intake
Secondary outcomes (2)
- Follow-up of glutathion concentration during 4 post operative days
Measured: during 4 post operative days
Monitoring of liver function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJun 2008
- Primary completionSep 2008
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Surgery and Treatment Post Operative With Paracetamol During 4 DaysStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Eric SCHNEIDER, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152502
- Sponsor's protocol ID
- CHU-0076
- Status last verified
- Jun 2010
- First submitted
- 28 Jun 2010
- Last updated
- 29 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracetamol Metabolism in Post Operative Conditions
- ClinicalTrials.gov ID
- NCT01152502
- Acronym / sponsor ID
- CHU-0076
- Keywords
- Post operative conditions, paracetamol metabolites
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Defined population
Key inclusion criteria (3 listed)
- aortic surgery
- treatment with intraveinous paracetamol (4 grammes daily during 4 days)
- patient agrees to participate
Key exclusion criteria (3 listed)
- - patient disagrees
- paracetamol contra-indication
- paracetamol intake 5 days before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
- Follow-up of glutathion concentration during 4 post operative days
Time frame: during 4 post operative days
Monitoring of liver function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric SCHNEIDER principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Surgery and Treatment Post Operative With Paracetamol During 4 Days, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2010.