NCT03284476

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

7.2 years

First QC Date

September 14, 2017

Last Update Submit

June 2, 2020

Conditions

Peritonitis

Keywords

Nosocomial PeritonitisCommunity-acquired PeritonitisPost-operative Peritonitis

Outcome Measures

Primary Outcomes (1)

  • In ICU stay main complications

    Nosocomial Infections (epidemiology, risk factors, antibiotic susceptibility of pathogens) Organ failures (incidence, risk factors)

    Within the first 28 days after ICU admission date

Secondary Outcomes (2)

  • Duration of mechanical ventilation

    In ICU (up to 90 days)

  • ICU length of stay

    In ICU (up to 90 days)

Other Outcomes (1)

  • Death

    In ICU (up to 90 days)

Study Arms (1)

ICU patients

Collection of medical data of Patients with peritonitis (nosocomial or community-acquired) or Patients with post-operative peritonitis

Other: Collection of medical data from ICU patients

Interventions

Collection of medical data from ICU patientsOTHER

Medical data collected on a electronic secured data base

ICU patients

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in ICU for peritonitis surgically treated

You may qualify if:

  • Nosocomial surgically treated Peritonitis
  • Or Community-Acquired surgically treated Peritonitis
  • Or Post-operative surgically treated Peritonitis

You may not qualify if:

  • Consent withdrawal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Angers University Hospital

Angers, 49000, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

Poitiers University Hospital

Poitiers, 86000, France

Location

Rennes University Hospital

Rennes, 35000, France

Location

Tours University Hospital

Tours, 37000, France

Location

MeSH Terms

Conditions

Peritonitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System Diseases

Study Officials

  • Karim Asehnoune, MD, PhD

    Non Affiliated

    STUDY CHAIR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 15, 2017

Study Start

April 1, 2013

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

June 4, 2020

Record last verified: 2020-06

Locations

FR(5)