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Post Surgically Treated Peritonitis Complications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03284476
Recruitment Status : Withdrawn (No inclusion)
First Posted : September 15, 2017
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date September 14, 2017
First Posted Date September 15, 2017
Last Update Posted Date June 4, 2020
Estimated Study Start Date April 2013
Actual Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 14, 2017)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 14, 2017)
  • Duration of mechanical ventilation [ Time Frame: In ICU (up to 90 days) ]
  • ICU length of stay [ Time Frame: In ICU (up to 90 days) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 14, 2017)
Death [ Time Frame: In ICU (up to 90 days) ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Post Surgically Treated Peritonitis Complications
Official Title A Prospective Cohort of Patients Hospitalized in West French Intensive Care Units for Peritonitis Surgically Treated
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.

Detailed Description Anonymous data will be collected by study coordinators in a secured e-database. Cross audit will be performed to check data.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients hospitalized in ICU for peritonitis surgically treated
Condition Peritonitis
Intervention Other: Collection of medical data from ICU patients
Medical data collected on a electronic secured data base
Study Groups/Cohorts ICU patients
Collection of medical data of Patients with peritonitis (nosocomial or community-acquired) or Patients with post-operative peritonitis
Intervention: Other: Collection of medical data from ICU patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: June 2, 2020)
0
Original Estimated Enrollment
 (submitted: September 14, 2017)
300
Actual Study Completion Date June 2020
Actual Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Consent withdrawal
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03284476
Other Study ID Numbers RC12_0207 doublon
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nantes University Hospital
Study Sponsor Nantes University Hospital
Collaborators Not Provided
Investigators
Study Chair: Karim Asehnoune, MD, PhD Non Affiliated
PRS Account Nantes University Hospital
Verification Date June 2020