Pleural Effusions After Cardiac Surgery

Pleural Effusions Are Associated With Adverse Outcomes 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.

Study Overview

• Status: Completed
• Conditions: Pleura; Effusion

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.

• Study Type: Observational
• Enrollment (Actual): 11198

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charite - Universitaetsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Group 0; patients without pleural effusion
Group 1; patients with pleural effusion
Group 2; patients with pleural Effusion and need of drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	In-Hospital mortality	an average of 30 days
hospital stay	Length of hospital stay	an average of 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need of drainage	Incidence of drainage in patients with pleural effusions	an average of 30 days
extubation	time to extubation	an average of 15 hours
renal replacement	incidence of renal replacement therapy	an average of 30 days
transfusions	number of transfusions needed	an average of 30 days
ICU stay	Length of Intensive Care Unit (ICU) stay	an average of 15 days

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Felix Balzer, MD, MSc, PhD, Charité Universitätsmedizin Berlin

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2006
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: PONTOS-Effusions

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No