Pleural Effusions After Cardiac Surgery

Completed

• Conditions: Pleura; Effusion

• Registration Number: NCT03409055
• Lead Sponsor: Charite University, Berlin, Germany

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.

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 Timeline

• Study Start: 2006-01-01
• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-24
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-07
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11198

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hospital stay	an average of 30 days	Length of hospital stay
mortality	an average of 30 days	In-Hospital mortality

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Charité - Universitaetsmedizin Berlin; 🇩🇪 Berlin, Germany