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OpenTrials
Completed

NCT Number: NCT03409055

Pleural Effusions After Cardiac Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité - Universitaetsmedizin Berlin

Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. mortality

    Time frame: an average of 30 days

    In-Hospital mortality

  2. hospital stay

    Time frame: an average of 30 days

    Length of hospital stay

Secondary outcomes

  1. Need of drainage

    Time frame: an average of 30 days

    Incidence of drainage in patients with pleural effusions

  2. extubation

    Time frame: an average of 15 hours

    time to extubation

  3. renal replacement

    Time frame: an average of 30 days

    incidence of renal replacement therapy

  4. transfusions

    Time frame: an average of 30 days

    number of transfusions needed

  5. ICU stay

    Time frame: an average of 15 days

    Length of Intensive Care Unit (ICU) stay

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Pleural Effusions Are Associated With Adverse Outcomes After Cardiac Surgery

Important dates

Study start
2006
Primary completion
2019
Study completion
2019
First posted
Jan 24, 2018
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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