Mesenteric Ischemia in the Emergency Department: a Retrospective Multicenter Study

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Mesenteric Ischemia

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Stefano Sartini, MD; Phone Number: +39 3402638395; Email: stefano.sartini@asl3.liguria.it
• Study Contact Backup: Name: Marcello Pastorelli, Professor; Phone Number: +39 0577586660; Email: marcello.pastorelli@unisi.it

Study Locations

• Italy
  • Liguria
    • Genova, Liguria, Italy, 16132
      • Recruiting
      • IRCCS San Martino
      • Contact: Stefano Sartini, MD; Phone Number: +393402638395; Email: stefano.sartini83@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
acute mesenteric ischemia; patients with abdominal pain and acute mesenteric ischemia
non-acute mesenteric ischemia; patients with abdominal pain without mesenteric ischemia

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Genova
• Collaborators: University of Bari; University of Siena
• Investigators: Study Chair: Vincenzo Savarino, Professor, University of Genova

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (ANTICIPATED): June 1, 2017
• Study Completion (ANTICIPATED): October 1, 2017

Study Registration Dates

• First Submitted: March 24, 2016
• First Submitted That Met QC Criteria: May 11, 2016
• First Posted (ESTIMATE): May 16, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Peritoneal Diseases; Disease Attributes; Gastrointestinal Diseases; Intestinal Diseases; Emergencies; Ischemia; Mesenteric Ischemia
• Other Study ID Numbers: RetroMesIsch

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES