Mesenteric Ischemia in the Emergency Department: a Retrospective Multicenter Study

Acute Mesenteric Ischemia Clinical Trial

Official title:

Acute Mesenteric Ischemia in the Emergency Department: Incidence, Early Recognition and Risk Stratification From an Observational Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02772913
• Other study ID #: RetroMesIsch
• 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
• 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

Related Conditions & MeSH terms

• Acute Mesenteric Ischemia
• Emergencies
• Ischemia
• Mesenteric Ischemia

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