Unilateral Pulmonary Edema After Minimal-invasive Mitral Valve Surgery

June 3, 2017 updated by: Dr. Jochen Renner, University Hospital Schleswig-Holstein

Unilateral Pulmonary Edema After Minimal-invasive Mitral Valve Surgery: a Retrospective Single Center Observation

Unilateral pulmonary edema after minimal-invasive mitral valve surgery is a rare but in some cases severe complications, sometimes causing extracorporeal life support. The investigators have observed over several years 5 cases of instantaneous postoperative severe pulmonary edema. This is a retrospective analysis of over 200 minimal-invasive mitral valve surgery procedure.

Study Overview

Status

Completed

Conditions

Detailed Description

Unilateral pulmonary edema after minimal-invasive mitral valve surgery is a rare but in some cases severe complications, sometimes causing extracorporeal life support. The investigators have observed over several years 5 cases of instantaneous postoperative severe pulmonary edema. After having studied the available literature on this particular topic the investigators have decided to prepare a retrospective analysis of over 200 minimal-invasive mitral valve surgery procedure focusing on radiological and clinical signs of unilateral pulmonary edema.

Study Type

Observational

Enrollment (Actual)

256

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitatsklinikum Schleswig-Holstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Collective of patients with relevant mitral valve disease scheduled for minimal-invasive mitral valve repair or replacement

Description

Inclusion Criteria:

  • >= 18 years of age

Exclusion Criteria:

  • urgent surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unilateral right sided pulmonary edema or congestion after surgery
Time Frame: Postoperatively within the first 12h after admission to intensive care unit
retrospective analysis using the electronic and the paper-based patient specific database
Postoperatively within the first 12h after admission to intensive care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Investigators

  • Principal Investigator: Jochen Renner, PD Dr., University Hospital Schleswig-Holstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

December 5, 2015

First Submitted That Met QC Criteria

January 11, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Actual)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 3, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IN-MIC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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