Registeranalysis for the Examination of NOMI | NCT02901808

Studies
Registeranalysis for the Examination of NOMI

NCT02901808

Sponsor

Universität des Saarlandes

Status

Unknown status

Last Update Posted

Oct 4, 2017Actual

Enrollment

10,000Actual

Phase

Not provided

Conditions

Mesenteric Ischemia

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2017Estimated

First Submitted Date

Aug 18, 2016

First Submission Date that Met QC Criteria

Sep 9, 2016

First Posted Date

Sep 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2017

Last Update Posted Date

Oct 4, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter Minko, Assistant Medical Director, Universität des SaarlandesPrincipal Investigator

Lead Sponsor

Universität des SaarlandesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NOMI		Patients suffering from NOMI
No-NOMI		Patients not suffering from NOMI

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Cardio-thoracic surgical patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arno Buecker, MD	Department of Diagnostic and Interventional Radiology	Study Director
Hans-Joachim Schäfers, MD	Department of Thoracic and Cardiovascular Surgery	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saarland University Medical Center		Homburg	Saarland	66421	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065666	Mesenteric Ischemia

Ancestor Terms

ID	Term
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010532	Peritoneal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided