NCT02655094

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
256

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 5, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

8 months

First QC Date

December 5, 2015

Last Update Submit

June 3, 2017

Conditions

Pulmonary Edema

Keywords

minimal-invasive surgery, mitral valve

Outcome Measures

Primary Outcomes (1)

  • Unilateral right sided pulmonary edema or congestion after surgery

    retrospective analysis using the electronic and the paper-based patient specific database

    Postoperatively within the first 12h after admission to intensive care unit

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \>= 18 years of age

You may not qualify if:

  • urgent surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Publications (1)

  • Renner J, Lorenzen U, Borzikowsky C, Schoeneich F, Cremer J, Haneya A, Hensler J, Panholzer B, Huenges K, Broch O. Unilateral pulmonary oedema after minimally invasive mitral valve surgery: a single-centre experience. Eur J Cardiothorac Surg. 2018 Apr 1;53(4):764-770. doi: 10.1093/ejcts/ezx399.

    PMID: 29186375DERIVED

MeSH Terms

Conditions

Pulmonary Edema

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Jochen Renner, PD Dr.

    University Hospital Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr.

Study Record Dates

First Submitted

December 5, 2015

First Posted

January 13, 2016

Study Start

February 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

June 6, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)