PeritonitisNCT03284476
Post Surgically Treated Peritonitis Complications
An observational study of Peritonitis, run by Nantes University Hospital at 5 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Peritonitis
- What is being tested?
- Collection of medical data 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 hospitalized in ICU for peritonitis surgically treated
Who may be able to join
- Nosocomial surgically treated Peritonitis
- Or Community-Acquired surgically treated Peritonitis
- Or Post-operative surgically treated Peritonitis
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: 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.
Read the detailed description
Anonymous data will be collected by study coordinators in a secured e-database. Cross audit will be performed to check data.
- Conditions
- Peritonitis
- Being tested
- Collection of medical data from ICU patients
- Keywords
- Nosocomial Peritonitis, Community-acquired Peritonitis, Post-operative Peritonitis
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of medical data from ICU patientsOther
Medical data collected on a electronic secured data base
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | Collection of medical data of Patients with peritonitis (nosocomial or community-acquired) or Patients with post-operative peritonitis Receives: Other: Collection of medical data 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 first 28 days after ICU admission date
Secondary outcomes (2)
Duration of mechanical ventilation
Measured: In ICU (up to 90 days)
ICU length of stay
Measured: In ICU (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 PeritonitisStudies 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
- NCT03284476
- Sponsor's protocol ID
- RC12_0207 doublon
- 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
- A Prospective Cohort of Patients Hospitalized in West French Intensive Care Units for Peritonitis Surgically Treated
- ClinicalTrials.gov ID
- NCT03284476
- Acronym / sponsor ID
- RC12_0207 doublon
- Conditions
- Peritonitis
- Keywords
- Nosocomial Peritonitis, Community-acquired Peritonitis, Post-operative Peritonitis
- 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 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.
Detailed description
Anonymous data will be collected by study coordinators in a secured e-database. Cross audit will be performed to check data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | Other: Collection of medical data from ICU patientsCollection of medical data of Patients with peritonitis (nosocomial or community-acquired) or Patients with post-operative peritonitis |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized in ICU for peritonitis surgically treated
Key inclusion criteria (3 listed)
- Nosocomial surgically treated Peritonitis
- Or Community-Acquired surgically treated Peritonitis
- Or Post-operative surgically treated Peritonitis
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 data from ICU patientsMedical data collected on a electronic secured data base | Other | ICU patients |
Primary outcome
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)
2 secondary outcomes
Duration of mechanical ventilation
Time frame: In ICU (up to 90 days)
ICU length of stay
Time frame: In ICU (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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Appendicitis, Perforated Appendicitis
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Pharmacokinetic Study of Rezafungin in Patients With Suspected Intra-Abdominal Candidiasis
Candidal Peritonitis
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Peritoneal Dialysis Registration System (PERSIST)
ESRD, Disorders Associated With Peritoneal Dialysis
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Nitazoxanide in Spontaneous Bacterial Peritonitis
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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 Peritonitis, 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 3 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 first 28 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.