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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02772913
Other study ID # RetroMesIsch
Secondary ID
Status Recruiting
Phase N/A
First received March 24, 2016
Last updated May 2, 2017
Start date August 2016
Est. completion date October 2017

Study information

Verified date May 2017
Source University of Genova
Contact Stefano Sartini, MD
Phone +39 3402638395
Email stefano.sartini@asl3.liguria.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date October 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Italy IRCCS San Martino Genova Liguria

Sponsors (3)

Lead Sponsor Collaborator
University of Genova University of Bari, University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary In-hospital mortality 30 days from hospital admission
Secondary in-hospital adverse outcome: cardiac arrest, ICU admission, septic shock, major bleeding. 30 days from hospital admission
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