Pleural Effusions After Cardiac Surgery

NCT ID: NCT03409055

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 11198 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-01
• Study Completion Date: 2019-12-31

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.

Conditions

Pleura; Effusion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group 0

patients without pleural effusion

No interventions assigned to this group

Group 1

patients with pleural effusion

No interventions assigned to this group

Group 2

patients with pleural Effusion and need of drainage

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Felix Balzer

Prof. Dr. med. Dr. rer. nat., MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felix Balzer, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Charite Universitätsmedizin Berlin

Locations

Charité - Universitaetsmedizin Berlin

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 36476289 (View on PubMed)

Other Identifiers

PONTOS-Effusions

Identifier Type: -

Identifier Source: org_study_id