Mesenteric Ischemia in the Emergency Department: a Retros... | NCT02772913

Studies
Mesenteric Ischemia in the Emergency Department: a Retrospective Multicenter Study

NCT02772913

Sponsor

University of Genova

Status

Unknown status

Last Update Posted

May 5, 2017Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Acute Mesenteric Ischemia

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Jun 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Mar 24, 2016

First Submission Date that Met QC Criteria

May 11, 2016

First Posted Date

May 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2017

Last Update Posted Date

May 5, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stefano Sartini, Medical doctor, Consultant in Emergency Medicine, University of GenovaPrincipal Investigator

Lead Sponsor

University of GenovaOTHER

Collaborators

Name	Class
University of Bari	OTHER
University of Siena	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Acute mesenteric ischemia is a life-threatening condition characterized by high mortality if unrecognized early. This multicenter retrospective observational study will review the emergency departments's (ED) notes of all patients discharged from hospital with a diagnosis of acute mesenteric ischemia in 2014-2015 comparing it with those admitted to the ED for abdominal pain in the same timeframe.

Detailed Description

Acute mesenteric ischemia is a condition characterized by non-specific presentation (typical clinical presentation is considered "abdominal pain out of proportion to examination") that may be under-recognized in the Emergency Department. Early identification and treatment is essential to improve outcome as mortality rate is attested around 80% if untreated within few hours from onset. The investigators aim to review the emergency department's clinical notes of patients discharged from hospital in 2014 and 2015 diagnosed with acute mesenteric ischemia. Furthermore the investigators will consider patients admitted for "abdominal pain" in the same time frame without acute mesenteric ischemia and we will compare presentation symptoms, medical history, medications, vitals, laboratory markers and imaging finding of the two groups. From this comparison, the investigators will be able to clarify the incidence among general population and among patients presenting acute abdominal pain. Finally, using multivariate analysis, the investigators may identify those variables predictive of acute mesenteric ischemia. This study will be held in three university hospitals and all data analyzed together.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
acute mesenteric ischemia		patients with abdominal pain and acute mesenteric ischemia
non-acute mesenteric ischemia		patients with abdominal pain without mesenteric ischemia

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
In-hospital mortality		30 days from hospital admission

Secondary Outcomes

Measure	Description	Time Frame
in-hospital adverse outcome: cardiac arrest, ICU admission, septic shock, major bleeding.		30 days from hospital admission

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ICD-9 diagnosis of acute mesenteric ischemia in 2014 and 2015
Admitted to hospital after Emergency Department assessment
age>18

Exclusion Criteria:

age<18
post-traumatic or post-surgery related acute mesenteric ischemia
lack of assessment in the Emergency Department

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients discharged from hospital with ICD-9 code related to acute mesenteric ischemia (1st cohort) compared with patients admitted for acute abdominal pain

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stefano Sartini, MD	Contact	+39 3402638395		stefano.sartini@asl3.liguria.it
Marcello Pastorelli, Professor	Contact	+39 0577586660		marcello.pastorelli@unisi.it

Overall Officials

Name	Affiliation	Role
Vincenzo Savarino, Professor	University of Genova	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS San Martino	Recruiting	Genoa	Liguria	16132	Italy

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided