Mesenteric IschemiaIRRE NOMINCT02901808
Registeranalysis for the Examination of NOMI
An observational study of Mesenteric Ischemia, run by Universität des Saarlandes at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Mesenteric Ischemia
- How many people
- 10,000 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cardio-thoracic surgical patients
Who may be able to join
- The investigators include anonymous data from patients with cardio-thoracic surgery
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mesenteric Ischemia
- Keywords
- NOMI, Angiography, Digital Subtraction Angiography (DSA)
- Medical subject headings
- Mesenteric Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NOMI | Patients suffering from NOMI | |
| No-NOMI | Patients not suffering from NOMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of NOMI
Clinical signs of NOMI
Measured: at the day of surgery, day zero
Secondary outcomes (3)
Length of stay
Length of stay will be measured upon the time spent on intensive care unit and in the hospital
Measured: 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
Measured: at the day of surgery, day zero up to 365 days
Mortality
Mortality will be measured upon patients leaving the hospital dead or alive.
Measured: at the day of surgery, day zero up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startJan 2008
- Primary completionDec 2014
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenteric IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Minko, Universität des Saarlandes
- Investigators
- Arno Buecker, MD, Study director, Department of Diagnostic and Interventional RadiologyHans-Joachim Schäfers, MD, Study director, Department of Thoracic and Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901808
- Sponsor's protocol ID
- 209/15
- Acronym
- IRRE NOMI
- Status last verified
- Oct 2017
- First submitted
- 18 Aug 2016
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Retrospective Registeranalysis for the Examination of Non-occlusive Mesenteric Ischemia (NOMI)
- ClinicalTrials.gov ID
- NCT02901808
- Acronym / sponsor ID
- IRRE NOMI / 209/15
- Conditions
- Mesenteric Ischemia
- Keywords
- NOMI, Angiography, Digital Subtraction Angiography (DSA)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOMI | – | –Patients suffering from NOMI |
| No-NOMI | – | –Patients not suffering from NOMI |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cardio-thoracic surgical patients
Key inclusion criteria (1 listed)
- The investigators include anonymous data from patients with cardio-thoracic surgery
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of NOMI
Time frame: at the day of surgery, day zero
Clinical signs of NOMI
3 secondary outcomes
Length of stay
Time frame: at the day of surgery, day zero up to 365 days
Mechanical ventilation
Time frame: at the day of surgery, day zero up to 365 days
Mortality
Time frame: at the day of surgery, day zero up to 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arno Buecker, MD study director
Department of Diagnostic and Interventional Radiology
Hans-Joachim Schäfers, MD study director
Department of Thoracic and Cardiovascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mesenteric Ischemia, run by Universität des Saarlandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of NOMI (time frame: at the day of surgery, day zero). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.