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Mesenteric Ischemia in the Emergency Department: a Retrospective Multicenter Study

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ClinicalTrials.gov Identifier: NCT02772913
Recruitment Status : Unknown
Verified May 2017 by Stefano Sartini, University of Genova.
Recruitment status was:  Recruiting
First Posted : May 16, 2016
Last Update Posted : May 5, 2017
Sponsor:
Collaborators:
University of Bari
University of Siena
Information provided by (Responsible Party):
Stefano Sartini, University of Genova

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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Acute Mesenteric Ischemia in the Emergency Department: Incidence, Early Recognition and Risk Stratification From an Observational Multicenter Study
Study Start Date : August 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : October 2017

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



Primary Outcome Measures :
  1. In-hospital mortality [ Time Frame: 30 days from hospital admission ]

Secondary Outcome Measures :
  1. in-hospital adverse outcome: cardiac arrest, ICU admission, septic shock, major bleeding. [ Time Frame: 30 days from hospital admission ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772913


Contacts
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Contact: Stefano Sartini, MD +39 3402638395 stefano.sartini@asl3.liguria.it
Contact: Marcello Pastorelli, Professor +39 0577586660 marcello.pastorelli@unisi.it

Locations
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Italy
IRCCS San Martino Recruiting
Genova, Liguria, Italy, 16132
Contact: Stefano Sartini, MD    +393402638395    stefano.sartini83@gmail.com   
Sponsors and Collaborators
University of Genova
University of Bari
University of Siena
Investigators
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Study Chair: Vincenzo Savarino, Professor University of Genova
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Responsible Party: Stefano Sartini, Medical doctor, Consultant in Emergency Medicine, University of Genova
ClinicalTrials.gov Identifier: NCT02772913    
Other Study ID Numbers: RetroMesIsch
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Mesenteric Ischemia
Emergencies
Ischemia
Disease Attributes
Pathologic Processes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peritoneal Diseases
Vascular Diseases
Cardiovascular Diseases