NCT03409055

Brief Summary

Pleural effusions occur commonly in patients recovering from cardiac surgery, however, the impact on outcomes is not well characterized. The purpose of this study is to characterize the outcomes of cardiac surgery patients with pleural effusions. All patients undergoing cardiac surgery between 2006 and 2019 were included in this observational, cross-sectional analysis using propensity matching.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11,198

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 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

Study Start

First participant enrolled

January 1, 2006

Completed
12.1 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

June 9, 2021

Status Verified

June 1, 2021

Enrollment Period

14 years

First QC Date

January 18, 2018

Last Update Submit

June 7, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • mortality

    In-Hospital mortality

    an average of 30 days

  • hospital stay

    Length of hospital stay

    an average of 30 days

Secondary Outcomes (5)

  • Need of drainage

    an average of 30 days

  • extubation

    an average of 15 hours

  • renal replacement

    an average of 30 days

  • transfusions

    an average of 30 days

  • ICU stay

    an average of 15 days

Study Arms (3)

Group 0

patients without pleural effusion

Group 1

patients with pleural effusion

Group 2

patients with pleural Effusion and need of drainage

Eligibility Criteria

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

All adult male and female patients who have undergone cardiac surgery in the period 01/06-12/19 at Campus Mitte in the Charité, approx. 11,000 patients.

You may qualify if:

  • In-patients of the Charité Universitätsmedizin Berlin
  • at least 18 years old
  • female or male sex
  • cardiosurgical intervention (OPS 5.35 and 5.36) between 01/06 and 12/19
  • post-operative monitoring in the intensive care unit

You may not qualify if:

  • previous cardiosurgical interventions during the same hospital stay
  • incomplete documentation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitaetsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (1)

  • Schiefenhovel F, Poncette AS, Boyle EM, von Heymann C, Menk M, Vorderwulbecke G, Grubitzsch H, Treskatsch S, Balzer F. Pleural effusions are associated with adverse outcomes after cardiac surgery: a propensity-matched analysis. J Cardiothorac Surg. 2022 Dec 7;17(1):298. doi: 10.1186/s13019-022-02050-y.

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Felix Balzer, MD, MSc, PhD

    Charite Universitätsmedizin Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Dr. rer. nat., MSc

Study Record Dates

First Submitted

January 18, 2018

First Posted

January 24, 2018

Study Start

January 1, 2006

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

June 9, 2021

Record last verified: 2021-06

Locations