Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-31 @ 11:49 AM
Study NCT ID:
NCT02901808
Status:
UNKNOWN
Last Update Posted:
2017-10-04
First Post:
2016-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registeranalysis for the Examination of NOMI
Sponsor:
Universität des Saarlandes
Organization:
Study Overview
Official Title:
Interdisciplinary Retrospective Registeranalysis for the Examination of Non-occlusive Mesenteric Ischemia (NOMI)
Status:
UNKNOWN
Status Verified Date:
2017-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRRE NOMI
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: