Pleural Effusions After Cardiac Surgery

Pleura; Effusion Clinical Trial

Official title:

Pleural Effusions Are Associated With Adverse Outcomes After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03409055
• Other study ID #: PONTOS-Effusions
• Status: Completed
• Start date: January 1, 2006
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11198
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pleura; Effusion
• Pleural Effusion

Locations

Country	Name	City	State
Germany	Charité - Universitaetsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	In-Hospital mortality	an average of 30 days
Primary	hospital stay	Length of hospital stay	an average of 30 days
Secondary	Need of drainage	Incidence of drainage in patients with pleural effusions	an average of 30 days
Secondary	extubation	time to extubation	an average of 15 hours
Secondary	renal replacement	incidence of renal replacement therapy	an average of 30 days
Secondary	transfusions	number of transfusions needed	an average of 30 days
Secondary	ICU stay	Length of Intensive Care Unit (ICU) stay	an average of 15 days