Registeranalysis for the Examination of NOMI

Mesenteric Ischemia Clinical Trial

— IRRE NOMI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02901808
• Other study ID #: 209/15
• Status: Active, not recruiting
• Phase: N/A
• First received: August 18, 2016
• Last updated: October 3, 2017
• Start date: January 2008
• Est. completion date: December 2017

Study information

• Verified date: October 2017
• Source: Saarland University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10000
• Est. completion date: December 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Ischemia
• Mesenteric Ischemia

Locations

Country	Name	City	State
Germany	Saarland University Medical Center	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
Saarland University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of NOMI	Clinical signs of NOMI	at the day of surgery, day zero
Secondary	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
Secondary	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
Secondary	Mortality	Mortality will be measured upon patients leaving the hospital dead or alive.	at the day of surgery, day zero up to 365 days