Pleural EffusionPONTOSNCT03379688
PDMS Outcome After Intensive Care, Organdysfunction and Monitoring
An observational study of Pleural Effusion and Blood Pressure, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The objective of the explorative registry study is to investigate outcome parameters in the routine treatment of patients who are monitored after heart surgery for either short or long-term treatment in the intensive care unit for close monitoring of blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pleural Effusion, Blood Pressure
- How many people
- 6,909 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2006to 1 Jul 2014
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult male and female patients who have undergone cardiac surgery in the period 01/06-12/13 at Campus Mitte in the Charité, approx. 7000 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 12/13.
- post-operative monitoring of anesthesiological 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: Patient Data Management System Monitored Outcome After Intensive Care, Organdysfunction and Monitoring
The objective of the explorative registry study is to investigate outcome parameters in the routine treatment of patients who are monitored after heart surgery for either short or long-term treatment in the intensive care unit for close monitoring of blood pressure.
Read the detailed description
The close monitoring of patients after cardiac surgery is regarded as standard. However, little is currently known about the influence on patient-related outcome parameters. Recently it has already been shown that intraoperative variability of blood pressure during heart surgery has a postoperative effect on 30-day mortality.
The aim of this retrospective study is to investigate the effects of different hemodynamic measurements and management after cardiac surgery on patient-specific outcome parameters.
- Conditions
- Pleural Effusion, Blood Pressure
- 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 |
|---|---|---|
| Cardiac surgery patients | Patients undergoing cardiac surgery at Charité Campus Mitte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure in range
Percentage of RR (Blood Pressure) measurements taken by each patient in the target range as a percentage of the total number of measurements taken by that patient.
Measured: Intensive Care stay, an average of 10 days
Blood pressure over range
Percentage of RR measurements of each patient above the target range in relation to the total of all measurements taken by that patient.
Measured: Intensive Care stay, an average of 10 days
Blood pressure below range
Percentage of RR measurements taken by each patient below the target range in relation to the total number of measurements taken by that patient.
Measured: Intensive Care stay, an average of 10 days
Secondary outcomes (17)
Hospital stay
Length of hospital stay
Measured: an average of 13 days
ICU stay
Intensive care unit length of stay
Measured: an average of 5 days
ICU readmission
Amount of hospital readmissions
Measured: an average of 30 days
Renal insufficiency - 1
Incidence of renal insufficiency
Measured: intensive care unit stay, an average of 5 days
Renal insufficiency - 2
dialysis duration
Measured: intensive care unit stay, an average of 5 days
Renal insufficiency - 3
Urine production
Measured: intensive care unit stay, an average of 5 days
Stroke
incidence of strokes
Measured: hospital length of stay, an average of 13 days
Drainage loss
Amount of postoperative drainage loss
Measured: intensive care unit stay, an average of 5 days
transfusions
number of transfusions needed
Measured: hospital length of stay, an average of 13 days
mortality rate-1
mortality rate after 90 days
Measured: 90 days
mortality rate-2
mortality rate after 180 days
Measured: 180 days
Pulse Contour Cardiac Output
data received from Pulse Contour Cardiac Output analyses
Measured: intensive care unit stay, an average of 5 days
mortality rate-3
mortality rate after 5 years
Measured: 5 years
mortality rate-4
mortality rate after 1 year
Measured: 1 year
Central venous pressure
central venous pressure on intensive care unit
Measured: intensive care unit stay, an average of 5 days
Pleural effusion
In-hospital incidence of pleural effusions postoperatively
Measured: hospital length of stay, an average of 13 days
Case cost
Case cost in Euro
Measured: hospital length of stay, an average of 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start1 Jan 2006
- Primary completion31 Dec 2013
- Study completion1 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pleural 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
- 6,909 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; PhD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379688
- Sponsor's protocol ID
- PONTOS
- Acronym
- PONTOS
- Status last verified
- Sep 2023
- First submitted
- 13 Dec 2017
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carl M, Alms A, Braun J, Dongas A, Erb J, Goetz A, Goepfert M, Gogarten W, Grosse J, Heller AR, Heringlake M, Kastrup M, Kroener A, Loer SA, Marggraf G, Markewitz A, Reuter D, Schmitt DV, Schirmer U, Wiesenack C, Zwissler B, Spies C. S3 guidelines for intensive care in cardiac surgery patients: hemodynamic monitoring and cardiocirculary system. Ger Med Sci. 2010 Jun 15;8:Doc12. doi: 10.3205/000101.
PubMed 20577643Aronson S, Stafford-Smith M, Phillips-Bute B, Shaw A, Gaca J, Newman M; Cardiothoracic Anesthesiology Research Endeavors. Intraoperative systolic blood pressure variability predicts 30-day mortality in aortocoronary bypass surgery patients. Anesthesiology. 2010 Aug;113(2):305-12. doi: 10.1097/ALN.0b013e3181e07ee9.
PubMed 20571360Aronson S, Dyke CM, Levy JH, Cheung AT, Lumb PD, Avery EG, Hu MY, Newman MF. Does perioperative systolic blood pressure variability predict mortality after cardiac surgery? An exploratory analysis of the ECLIPSE trials. Anesth Analg. 2011 Jul;113(1):19-30. doi: 10.1213/ANE.0b013e31820f9231. Epub 2011 Feb 23.
PubMed 21346163
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Data Management System Monitored Outcome After Intensive Care, Organdysfunction and Monitoring
- ClinicalTrials.gov ID
- NCT03379688
- Acronym / sponsor ID
- PONTOS / PONTOS
- Conditions
- Pleural Effusion, Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,909 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 1 Jul 2014 (actual)
- First posted
- 20 Dec 2017 (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.
The objective of the explorative registry study is to investigate outcome parameters in the routine treatment of patients who are monitored after heart surgery for either short or long-term treatment in the intensive care unit for close monitoring of blood pressure.
Detailed description
The close monitoring of patients after cardiac surgery is regarded as standard. However, little is currently known about the influence on patient-related outcome parameters. Recently it has already been shown that intraoperative variability of blood pressure during heart surgery has a postoperative effect on 30-day mortality.
The aim of this retrospective study is to investigate the effects of different hemodynamic measurements and management after cardiac surgery on patient-specific outcome parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery patients | – | –Patients undergoing cardiac surgery at Charité Campus Mitte |
Who may qualify
- Ages
- 18 to 100 years
- 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 01/06-12/13 at Campus Mitte in the Charité, approx. 7000 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 12/13.
- post-operative monitoring of anesthesiological 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
Blood pressure in range
Time frame: Intensive Care stay, an average of 10 days
Percentage of RR (Blood Pressure) measurements taken by each patient in the target range as a percentage of the total number of measurements taken by that patient.
Blood pressure over range
Time frame: Intensive Care stay, an average of 10 days
Percentage of RR measurements of each patient above the target range in relation to the total of all measurements taken by that patient.
Blood pressure below range
Time frame: Intensive Care stay, an average of 10 days
Percentage of RR measurements taken by each patient below the target range in relation to the total number of measurements taken by that patient.
17 secondary outcomes
Hospital stay
Time frame: an average of 13 days
ICU stay
Time frame: an average of 5 days
ICU readmission
Time frame: an average of 30 days
Renal insufficiency - 1
Time frame: intensive care unit stay, an average of 5 days
Renal insufficiency - 2
Time frame: intensive care unit stay, an average of 5 days
Renal insufficiency - 3
Time frame: intensive care unit stay, an average of 5 days
Stroke
Time frame: hospital length of stay, an average of 13 days
Drainage loss
Time frame: intensive care unit stay, an average of 5 days
transfusions
Time frame: hospital length of stay, an average of 13 days
mortality rate-1
Time frame: 90 days
mortality rate-2
Time frame: 180 days
Pulse Contour Cardiac Output
Time frame: intensive care unit stay, an average of 5 days
mortality rate-3
Time frame: 5 years
mortality rate-4
Time frame: 1 year
Central venous pressure
Time frame: intensive care unit stay, an average of 5 days
Pleural effusion
Time frame: hospital length of stay, an average of 13 days
Case cost
Time frame: hospital length of stay, an average of 13 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 8 Sep 2023.
- Background: PubMed 20577643Carl M, Alms A, Braun J, Dongas A, Erb J, Goetz A, Goepfert M, Gogarten W, Grosse J, Heller AR, Heringlake M, Kastrup M, Kroener A, Loer SA, Marggraf G, Markewitz A, Reuter D, Schmitt DV, Schirmer U, Wiesenack C, Zwissler B, Spies C. S3 guidelines for intensive care in cardiac surgery patients: hemodynamic monitoring and cardiocirculary system. Ger Med Sci. 2010 Jun 15;8:Doc12. doi: 10.3205/000101.
- Background: PubMed 20571360Aronson S, Stafford-Smith M, Phillips-Bute B, Shaw A, Gaca J, Newman M; Cardiothoracic Anesthesiology Research Endeavors. Intraoperative systolic blood pressure variability predicts 30-day mortality in aortocoronary bypass surgery patients. Anesthesiology. 2010 Aug;113(2):305-12. doi: 10.1097/ALN.0b013e3181e07ee9.
- Background: PubMed 21346163Aronson S, Dyke CM, Levy JH, Cheung AT, Lumb PD, Avery EG, Hu MY, Newman MF. Does perioperative systolic blood pressure variability predict mortality after cardiac surgery? An exploratory analysis of the ECLIPSE trials. Anesth Analg. 2011 Jul;113(1):19-30. doi: 10.1213/ANE.0b013e31820f9231. Epub 2011 Feb 23.
- Individual participant dataSharing planned: No
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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; PhD principal investigator
Charite University, Berlin, Germany
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 Pleural Effusion and Blood Pressure, 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 8 Sep 2023. 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?
Blood pressure in range (time frame: Intensive Care stay, an average of 10 days). The study lists 3 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 NCT03379688, which also lists 3 linked publications.
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 8 Sep 2023.