- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03284476
Post Surgically Treated Peritonitis Complications
June 2, 2020 updated by: Nantes University Hospital
A Prospective Cohort of Patients Hospitalized in West French Intensive Care Units for Peritonitis Surgically Treated
The purpose of this observational study is to investigate the management and the complications associated wtih surgically treated peritonitis.
Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Anonymous data will be collected by study coordinators in a secured e-database.
Cross audit will be performed to check data.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Angers, France, 49000
- Angers University Hospital
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Nantes, France, 44093
- Nantes University Hospital
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Poitiers, France, 86000
- Poitiers University Hospital
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Rennes, France, 35000
- Rennes University Hospital
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Tours, France, 37000
- Tours University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients hospitalized in ICU for peritonitis surgically treated
Description
Inclusion Criteria:
- Nosocomial surgically treated Peritonitis
- Or Community-Acquired surgically treated Peritonitis
- Or Post-operative surgically treated Peritonitis
Exclusion Criteria:
- Consent withdrawal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ICU patients
Collection of medical data of Patients with peritonitis (nosocomial or community-acquired) or Patients with post-operative peritonitis
|
Medical data collected on a electronic secured data base
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
In ICU stay main complications
Time Frame: Within the first 28 days after ICU admission date
|
Nosocomial Infections (epidemiology, risk factors, antibiotic susceptibility of pathogens) Organ failures (incidence, risk factors)
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Within the first 28 days after ICU admission date
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Duration of mechanical ventilation
Time Frame: In ICU (up to 90 days)
|
In ICU (up to 90 days)
|
|
ICU length of stay
Time Frame: In ICU (up to 90 days)
|
In ICU (up to 90 days)
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Death
Time Frame: In ICU (up to 90 days)
|
In ICU (up to 90 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Karim Asehnoune, MD, PhD, Non Affiliated
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2013
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
June 1, 2020
Study Registration Dates
First Submitted
September 14, 2017
First Submitted That Met QC Criteria
September 14, 2017
First Posted (Actual)
September 15, 2017
Study Record Updates
Last Update Posted (Actual)
June 4, 2020
Last Update Submitted That Met QC Criteria
June 2, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC12_0207 doublon
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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