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Registeranalysis for the Examination of NOMI (IRRE NOMI)

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ClinicalTrials.gov Identifier: NCT02901808
Recruitment Status : Unknown
Verified October 2017 by Peter Minko, Saarland University.
Recruitment status was:  Active, not recruiting
First Posted : September 15, 2016
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Peter Minko, Saarland University

Brief Summary:
The registry includes patients undergoing cardiovascular and thoracic surgery at the Saarland University Medical Center, Homburg/Saar, Germany. This study is a monocentric, retrospective study investigating the development of NOMI and outcome of patients.

Condition or disease
Mesenteric Ischemia

Detailed Description:

All data were acquired from the hospital electronic health record and the picture archiving computer system (PACS).

NOMI was suspected if the following clinical signs occured:

new onset of oliguria (urine output <0.5 mL/kg/hour for at least 6 hours) or anuria, abdominal distention with decreased or absent bowel sounds, elevated serum lactate levels >5.0mmol/L or metabolic acidosis (base excess <-5mmol/L).

In accordance to the definition of cardiogenic shock angiography was performed in patients with a systolic blood pressure >90 mmHg and a cardiac index >1.8 L/minute/m².


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Study Type : Observational
Actual Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Interdisciplinary Retrospective Registeranalysis for the Examination of Non-occlusive Mesenteric Ischemia (NOMI)
Study Start Date : January 2008
Actual Primary Completion Date : December 2014
Estimated Study Completion Date : December 2017

Group/Cohort
NOMI
Patients suffering from NOMI
No-NOMI
Patients not suffering from NOMI



Primary Outcome Measures :
  1. Development of NOMI [ Time Frame: at the day of surgery, day zero ]
    Clinical signs of NOMI


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: at the day of surgery, day zero up to 365 days ]
    Length of stay will be measured upon the time spent on intensive care unit and in the hospital

  2. Mechanical ventilation [ Time Frame: at the day of surgery, day zero up to 365 days ]
    Length of mechanical ventilation will be measured upon the time spent on intensive care unit

  3. Mortality [ Time Frame: at the day of surgery, day zero up to 365 days ]
    Mortality will be measured upon patients leaving the hospital dead or alive.



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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cardio-thoracic surgical patients
Criteria

Inclusion Criteria:

  • The investigators include anonymous data from patients with cardio-thoracic surgery

Exclusion Criteria:

  • None

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): NCT02901808


Locations
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Germany
Saarland University Medical Center
Homburg, Saarland, Germany, 66421
Sponsors and Collaborators
Saarland University
Investigators
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Study Director: Arno Buecker, MD Department of Diagnostic and Interventional Radiology
Study Director: Hans-Joachim Schäfers, MD Department of Thoracic and Cardiovascular Surgery

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Responsible Party: Peter Minko, Assistant Medical Director, Saarland University
ClinicalTrials.gov Identifier: NCT02901808     History of Changes
Other Study ID Numbers: 209/15
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Peter Minko, Saarland University:
NOMI
Angiography
Digital Subtraction Angiography (DSA)
Additional relevant MeSH terms:
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Mesenteric Ischemia
Ischemia
Pathologic Processes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peritoneal Diseases
Vascular Diseases
Cardiovascular Diseases