NCT02901808

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 4, 2017

Status Verified

October 1, 2017

Enrollment Period

6.9 years

First QC Date

August 18, 2016

Last Update Submit

October 3, 2017

Conditions

Mesenteric Ischemia

Keywords

NOMIAngiographyDigital Subtraction Angiography (DSA)

Outcome Measures

Primary Outcomes (1)

  • Development of NOMI

    Clinical signs of NOMI

    at the day of surgery, day zero

Secondary Outcomes (3)

  • Length of stay

    at the day of surgery, day zero up to 365 days

  • Mechanical ventilation

    at the day of surgery, day zero up to 365 days

  • Mortality

    at the day of surgery, day zero up to 365 days

Study Arms (2)

NOMI

Patients suffering from NOMI

No-NOMI

Patients not suffering from NOMI

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cardio-thoracic surgical patients

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saarland University Medical Center

Homburg, Saarland, 66421, Germany

Location

MeSH Terms

Conditions

Mesenteric Ischemia

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPeritoneal DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Arno Buecker, MD

    Department of Diagnostic and Interventional Radiology

    STUDY DIRECTOR

  • Hans-Joachim Schäfers, MD

    Department of Thoracic and Cardiovascular Surgery

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Medical Director

Study Record Dates

First Submitted

August 18, 2016

First Posted

September 15, 2016

Study Start

January 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2017

Last Updated

October 4, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)