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WithdrawnNCT03284476Updated Jun 4, 2020

Post Surgically Treated Peritonitis Complications

An observational study in Peritonitis, sponsored by Nantes University Hospital. Withdrawn at 5 sites in France. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2020-06-04.

Sponsored by Nantes University Hospital · Observational

Why this study was withdrawn
No inclusion
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
15 Years and older
Sex
All
01

Study 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 the detailed description

Anonymous data will be collected by study coordinators in a secured e-database. Cross audit will be performed to check data.

02

Conditions studied

  • Peritonitis

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Keywords

  • Nosocomial Peritonitis
  • Community-acquired Peritonitis
  • Post-operative Peritonitis
03

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients hospitalized in ICU for peritonitis surgically treated

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Consent withdrawal
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherCollection of medical data from ICU patients

    Medical data collected on a electronic secured data base

05

What researchers measure

Primary outcomes

  1. In ICU stay main complications

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

    Time frame: Within the first 28 days after ICU admission date

Secondary outcomes

  1. Duration of mechanical ventilation

    Time frame: In ICU (up to 90 days)

  2. ICU length of stay

    Time frame: In ICU (up to 90 days)

Other outcomes

  1. Death

    Time frame: In ICU (up to 90 days)

06

Study locations

5 sites
  • Angers University Hospital
    Angers, 49000, France
  • Nantes University Hospital
    Nantes, 44093, France
  • Poitiers University Hospital
    Poitiers, 86000, France
  • Rennes University Hospital
    Rennes, 35000, France
  • Tours University Hospital
    Tours, 37000, France
07

Registry details

Key details

Study ID
NCT03284476
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Sep 15, 2017
Start date
Apr 2013 (estimated)
Primary completion
Jun 2020
Completion
Jun 2020
Last update
Jun 4, 2020

Study contacts

Karim Asehnoune, MD, PhD
study chair · Non Affiliated

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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