Pleura; EffusionNCT03409055
Pleural Effusions After Cardiac Surgery
An observational study of Pleura; Effusion, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleura; Effusion
- How many people
- 11,198 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2006to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- previous cardiosurgical interventions during the same hospital stay
- incomplete documentation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 0 | patients without pleural effusion | |
| Group 1 | patients with pleural effusion | |
| Group 2 | patients with pleural Effusion and need of drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
In-Hospital mortality
Measured: an average of 30 days
hospital stay
Length of hospital stay
Measured: an average of 30 days
Secondary outcomes (5)
Need of drainage
Incidence of drainage in patients with pleural effusions
Measured: an average of 30 days
extubation
time to extubation
Measured: an average of 15 hours
renal replacement
incidence of renal replacement therapy
Measured: an average of 30 days
transfusions
number of transfusions needed
Measured: an average of 30 days
ICU stay
Length of Intensive Care Unit (ICU) stay
Measured: an average of 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start1 Jan 2006
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pleura; EffusionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11,198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix Balzer, Charite University, Berlin, Germany
- Investigators
- Felix Balzer, MD, MSc, PhD, Principal investigator, Charite Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409055
- Sponsor's protocol ID
- PONTOS-Effusions
- Status last verified
- Jun 2021
- First submitted
- 18 Jan 2018
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36476289
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pleural Effusions Are Associated With Adverse Outcomes After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03409055
- Acronym / sponsor ID
- PONTOS-Effusions
- Conditions
- Pleura; Effusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,198 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 0 | – | –patients without pleural effusion |
| Group 1 | – | –patients with pleural effusion |
| Group 2 | – | –patients with pleural Effusion and need of drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- previous cardiosurgical interventions during the same hospital stay
- incomplete documentation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality
Time frame: an average of 30 days
In-Hospital mortality
hospital stay
Time frame: an average of 30 days
Length of hospital stay
5 secondary outcomes
Need of drainage
Time frame: an average of 30 days
extubation
Time frame: an average of 15 hours
renal replacement
Time frame: an average of 30 days
transfusions
Time frame: an average of 30 days
ICU stay
Time frame: an average of 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Derived from this study: PubMed 36476289Schiefenhovel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Balzer, MD, MSc, PhD principal investigator
Charite Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleura; Effusion, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: an average of 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03409055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.