Italian Register for the Study of Complicated Intra-Abdominal Infections

NCT ID: NCT03678298

Last Updated: 2018-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-04-01

Brief Summary

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The study will identify the epidemiological and treatment profiles of acute peritonitis in Italy

Detailed Description

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The primary objectives of the study are: (1) the identification of specific risk factors for in-hospital mortality, in order to perfect the clinical management of patients with complicated intra-abdominal infections (cIAIs); (2) the identification of specific risk factors for multi-drug resistant organisms (MDROs) isolation in patients with cIAIs, in order to improve the adequacy of empirical antimicrobial therapy.

The secondary objectives are: (1) the description of the clinical, diagnostic and treatment profiles of patients with cIAIs in Italian surgical departments; (2) the analysis of epidemiology and patterns of antimicrobial susceptibility of the microorganisms isolated in samples in intra-operative samples of peritoneal fluid or purulent exudate/discrete abscesses in patients with cIAIs; (3) the identification of specific risk factors for post-operative complications in patients with cIAIs.

Conditions

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Complicated Intra-abdominal Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Epidemiological/treatment profiles

All consecutively hospitalized adult patients (older than 18 years of age) undergoing surgery, interventional drainage or conservative treatment, with diagnosis of cIAIs (defined as abdominal infections originating in an organ cavity, extending into the peritoneal space, and forming an abscess or peritonitis, will be included in the study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

All consecutively hospitalized adult patients (older than 18 years of age) undergoing surgery, interventional drainage or conservative treatment, with diagnosis of cIAIs (defined as abdominal infections originating in an organ cavity, extending into the peritoneal space, and forming an abscess or peritonitis)

Exclusion Criteria

Patients younger than 16 years-old, patients with pancreatitis or primary peritonitis
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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World Society of Emergency Surgery

OTHER

Sponsor Role lead

Responsible Party

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Massimo Sartelli

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Massimo Sartelli, MD

Role: PRINCIPAL_INVESTIGATOR

WSES

Locations

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WSES

Bologna, , Italy

Site Status

Countries

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Italy

Central Contacts

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Massimo Sartelli, MD

Role: CONTACT

00393405369701

Fausto Catena, MD

Role: CONTACT

Facility Contacts

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Massimo Sartelli, MD

Role: primary

00393405369701

Other Identifiers

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1/2018

Identifier Type: -

Identifier Source: org_study_id

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