Registeranalysis for the Examination of NOMI (IRRE NOMI)

Interdisciplinary Retrospective Registeranalysis for the Examination of Non-occlusive Mesenteric Ischemia (NOMI)

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.

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 10000

Contacts and Locations

Study Locations

• Germany
  • Saarland
    • Homburg, Saarland, Germany, 66421
      • Saarland University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cardio-thoracic surgical patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of NOMI	Clinical signs of NOMI	at the day of surgery, day zero

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Length of stay will be measured upon the time spent on intensive care unit and in the hospital	at the day of surgery, day zero up to 365 days
Mechanical ventilation	Length of mechanical ventilation will be measured upon the time spent on intensive care unit	at the day of surgery, day zero up to 365 days
Mortality	Mortality will be measured upon patients leaving the hospital dead or alive.	at the day of surgery, day zero up to 365 days

Collaborators and Investigators

• Sponsor: Universität des Saarlandes
• Investigators: Study Director: Arno Buecker, MD, Department of Diagnostic and Interventional Radiology; Study Director: Hans-Joachim Schäfers, MD, Department of Thoracic and Cardiovascular Surgery

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2014
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: August 18, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimate): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): October 4, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Angiography; NOMI; Digital Subtraction Angiography (DSA)
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Peritoneal Diseases; Gastrointestinal Diseases; Intestinal Diseases; Ischemia; Mesenteric Ischemia
• Other Study ID Numbers: 209/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No