Post Surgically Treated Peritonitis Complications

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03284476
• Collaborator: (none)
• Enrollment: 0
• Locations: 5
• Anticipated Duration (Months): 86
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peritonitis	Other: Collection of medical data from ICU patients

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

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Cohort of Patients Hospitalized in West French Intensive Care Units for Peritonitis Surgically Treated
• Anticipated Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Jun 1, 2020
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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; Medical data collected on a electronic secured data base

Outcome Measures

Primary Outcome Measures

1. In ICU stay main complications [Within the first 28 days after ICU admission date]

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

Secondary Outcome Measures

1. Duration of mechanical ventilation [In ICU (up to 90 days)]

2. ICU length of stay [In ICU (up to 90 days)]

Other Outcome Measures

1. Death [In ICU (up to 90 days)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Nosocomial surgically treated Peritonitis

• Or Community-Acquired surgically treated Peritonitis

• Or Post-operative surgically treated Peritonitis

Exclusion Criteria:

• Consent withdrawal

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Angers University Hospital	Angers		France	49000
2	Nantes University Hospital	Nantes		France	44093
3	Poitiers University Hospital	Poitiers		France	86000
4	Rennes University Hospital	Rennes		France	35000
5	Tours University Hospital	Tours		France	37000

Sponsors and Collaborators

• Nantes University Hospital

Investigators

• Study Chair: Karim Asehnoune, MD, PhD, Non Affiliated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT03284476
• Other Study ID Numbers: RC12_0207 doublon
• First Posted: Sep 15, 2017
• Last Update Posted: Jun 4, 2020
• Last Verified: Jun 1, 2020

• Keywords provided by Nantes University Hospital: Nosocomial Peritonitis; Community-acquired Peritonitis; Post-operative Peritonitis
• Additional relevant MeSH terms: Peritonitis

Study Results

No Results Posted as of Jun 4, 2020