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CompletedNCT03409055Updated Jun 9, 2021

Pleural Effusions After Cardiac Surgery

An observational study in Pleura; Effusion, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-09.

Sponsored by Charite University, Berlin, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
11,198
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Pleural effusions are common in patients recovering from cardiac surgery. Symptomatic patients with pleural effusions complain of shortness of breath, cough, chest pain and are more hypoxic and tachypneic. Clinically significant effusions can slow recovery in the hospital and beyond, and are a critical source of hospital readmissions after discharge. It is not well characterized how this impacts hospital outcomes. Further it is unknown if the effusions themselves are associated with impaired outcomes, or if pleural effusions simply arise in more complicated, older patients, thus suggesting the impaired outcomes are the result of coexisting morbidities. To better understand the impact of this complication and to address the question mentioned before, this study was carried out to determine the clinical and economic outcomes of pleural effusions in propensity-matched patients during early recovery from cardiac surgery. To compare patient groups with and without pleural effusion, the following baseline characteristics were used: e.g. age, sex, body-mass-index, priority of surgery, type of surgery, duration of surgery, APACHE II Score of patients on admission in the ICU.

02

Conditions studied

  • Pleura; Effusion

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • previous cardiosurgical interventions during the same hospital stay
  • incomplete documentation.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
11,198 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 0

    patients without pleural effusion

  • Group 1

    patients with pleural effusion

  • Group 2

    patients with pleural Effusion and need of drainage

05

What researchers measure

Primary outcomes

  1. mortality

    In-Hospital mortality

    Time frame: an average of 30 days

  2. hospital stay

    Length of hospital stay

    Time frame: an average of 30 days

Secondary outcomes

  1. Need of drainage

    Incidence of drainage in patients with pleural effusions

    Time frame: an average of 30 days

  2. extubation

    time to extubation

    Time frame: an average of 15 hours

  3. renal replacement

    incidence of renal replacement therapy

    Time frame: an average of 30 days

  4. transfusions

    number of transfusions needed

    Time frame: an average of 30 days

  5. ICU stay

    Length of Intensive Care Unit (ICU) stay

    Time frame: an average of 15 days

06

Study locations

1 site
  • Charité - Universitaetsmedizin Berlin
    Berlin, 10117, Germany
07

Registry details

Key details

Study ID
NCT03409055
Lead sponsor
Charite University, Berlin, Germany
Responsible party
Felix Balzer (Prof. Dr. med. Dr. rer. nat., MSc, Charite University, Berlin, Germany) — Principal investigator
First posted
Jan 24, 2018
Start date
Jan 1, 2006
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Jun 9, 2021

Study contacts

Felix Balzer, MD, MSc, PhD
principal investigator · Charite Universitätsmedizin Berlin

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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