PancreatitisNCT03284489
Post Pancreatitis Complications Study (Based on a Prospective Data Base)
An observational study of Pancreatitis, run by Nantes University Hospital at 5 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Pancreatitis
- What is being tested?
- Collection of medical datas from ICU patients
- How many people
- 0 participants
- Where
- 5 sitesFrance
- Study dates
- Apr 2013to Jun 2020
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pancreatitis hospitalized in ICU
Who may be able to join
- pancreatitis
Who cannot join
- consent withdrawal
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Angers University Hospital
Angers, 49000
Nantes University Hospital
Nantes, 44093
Poitiers University Hospital
Poitiers, 86000
Rennes University Hospital
Rennes, 35000
Tours University Hospital
Tours, 37000
About this study
Official title: 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.
Read the detailed description
Anonymous datas will be collected by study coordinators in a secured e-database.
Cross audit will be performed to check datas.
- Conditions
- Pancreatitis
- Being tested
- Collection of medical datas from ICU patients
- Keywords
- Pancreatitis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of medical datas from ICU patientsOther
Collection of medical datas from ICU patients with pancreatitis on a secured electronic database
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | Patients with pancreatitis Receives: Other: Collection of medical datas from ICU patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
In ICU stay main complications
Nosocomial Infections (epidemiology, risk factors, antibiotic susceptibility of pathogens) Organ failures (incidence, risk factors)
Measured: Within the 28 first days after ICU admission date
Secondary outcomes (2)
Duration of Mechanical Ventilation
Measured: During ICU stay (up to 90 days)
Length of ICU stay
Measured: During ICU stay (up to 90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study startApr 2013 (estimated)
- Primary completionJun 2020
- Study completionJun 2020
Why it stopped: No inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim Asehnoune, MD,PhD, Study chair, Non-Affiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284489
- Sponsor's protocol ID
- RC12_0207 doublon 2
- Status last verified
- Jun 2020
- First submitted
- 14 Sep 2017
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort of Patients With Pancreatitis Hospitalized in West French Intensive Care Units
- ClinicalTrials.gov ID
- NCT03284489
- Acronym / sponsor ID
- RC12_0207 doublon 2
- Conditions
- Pancreatitis
- Keywords
- Pancreatitis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No inclusion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Apr 2013 (estimated)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 15 Sep 2017 (actual)
- 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.
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.
Detailed description
Anonymous datas will be collected by study coordinators in a secured e-database.
Cross audit will be performed to check datas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | Other: Collection of medical datas from ICU patientsPatients with pancreatitis |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pancreatitis hospitalized in ICU
Key inclusion criteria (1 listed)
- pancreatitis
Key exclusion criteria (1 listed)
- consent withdrawal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of medical datas from ICU patientsCollection of medical datas from ICU patients with pancreatitis on a secured electronic database | Other | ICU patients |
Primary outcome
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)
2 secondary outcomes
Duration of Mechanical Ventilation
Time frame: During ICU stay (up to 90 days)
Length of ICU stay
Time frame: During ICU stay (up to 90 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
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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.
Karim Asehnoune, MD,PhD study chair
Non-Affiliated
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis, run by Nantes University Hospital at 5 sites 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
In ICU stay main complications (time frame: Within the 28 first days after ICU admission date). 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 4 Jun 2020.