Clinical trial NCT03409055: Pleural Effusions After Cardiac Surgery
Official title: Pleural Effusions Are Associated With Adverse Outcomes After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleura; Effusion
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 11198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: mortality
timeFrame: an average of 30 days
measure: hospital stay
timeFrame: an average of 30 days
Secondary outcomes:
measure: Need of drainage
timeFrame: an average of 30 days
measure: extubation
timeFrame: an average of 15 hours
measure: renal replacement
timeFrame: an average of 30 days
measure: transfusions
timeFrame: an average of 30 days
measure: ICU stay
timeFrame: an average of 15 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitaetsmedizin Berlin
Study officials:
affiliation: Charite Universitätsmedizin Berlin
name: Felix Balzer, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: