- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03284489
Post Pancreatitis Complications Study (Based on a Prospective Data Base)
June 2, 2020 updated by: Nantes University Hospital
Prospective Cohort of Patients With Pancreatitis Hospitalized in West French Intensive Care Units
The purpose of this observational epidemiological study is to investigate the management and the complications associated with pancreatitis.
Datas 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Withdrawn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 datas will be collected by study coordinators in a secured e-database.
Cross audit will be performed to check datas.
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
-
-
-
Angers, France, 49000
- Angers University Hospital
-
Nantes, France, 44093
- Nantes University Hospital
-
Poitiers, France, 86000
- Poitiers university hospital
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Rennes, France, 35000
- Rennes University Hospital
-
Tours, France, 37000
- Tours university Hospital
-
-
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 with pancreatitis hospitalized in ICU
Description
Inclusion Criteria:
- pancreatitis
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
Patients with pancreatitis
|
Collection of medical datas from ICU patients with pancreatitis on a secured electronic database
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
In ICU stay main complications
Time Frame: Within the 28 first days after ICU admission date
|
Nosocomial Infections (epidemiology, risk factors, antibiotic susceptibility of pathogens) Organ failures (incidence, risk factors)
|
Within the 28 first days after ICU admission date
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of Mechanical Ventilation
Time Frame: During ICU stay (up to 90 days)
|
During ICU stay (up to 90 days)
|
Length of ICU stay
Time Frame: During ICU stay (up to 90 days)
|
During ICU stay (up to 90 days)
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Death
Time Frame: During ICU stay (up to 90 days)
|
During ICU stay (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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC12_0207 doublon 2
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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