Central Venous PressureNCT03423420
Pontos-Central Venous Pressure and Cardiac Surgery
An observational study of Central Venous Pressure, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Recent studies indicated the central venous pressure (CVP) as a prognostic marker. Therefore, we retrospectively analyzed the CVP on admission to the intensive care unit (ICU) in cardiac surgery patients regarding its prognostic value for morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Pressure
- How many people
- 5,945 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2006to 31 Dec 2013
- 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 01/06-12/13 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: High Central Venous Pressure After Cardiac Surgery is Associated With Increased Morbidity and Mortality
Recent studies indicated the central venous pressure (CVP) as a prognostic marker. Therefore, we retrospectively analyzed the CVP on admission to the intensive care unit (ICU) in cardiac surgery patients regarding its prognostic value for morbidity and mortality.
- Conditions
- Central Venous Pressure
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
Secondary outcomes (13)
Central venous pressure
central venous pressure on intensive care unit
Measured: intensive care unit stay, an average of 5 days
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
mortality rate-1
mortality rate after 90 days
Measured: 90 days
mortality rate-2
mortality rate after 180 days
Measured: 180 days
mortality rate-3
mortality rate after 3 years
Measured: 3 years
mortality rate-4
mortality rate after 1 year
Measured: 1 year
mortality rate-5
mortality rate after 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start1 Jan 2006
- Primary completion31 Dec 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous PressureStudies 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
- 5,945 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
- NCT03423420
- Sponsor's protocol ID
- PONTOS-CVP
- Status last verified
- Jul 2019
- First submitted
- 25 Jan 2018
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Central Venous Pressure After Cardiac Surgery is Associated With Increased Morbidity and Mortality
- ClinicalTrials.gov ID
- NCT03423420
- Acronym / sponsor ID
- PONTOS-CVP
- Conditions
- Central Venous Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,945 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
- 31 Dec 2013 (actual)
- First posted
- 6 Feb 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.
Recent studies indicated the central venous pressure (CVP) as a prognostic marker. Therefore, we retrospectively analyzed the CVP on admission to the intensive care unit (ICU) in cardiac surgery patients regarding its prognostic value for morbidity and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
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 01/06-12/13 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
mortality
Time frame: an average of 30 days
In-Hospital mortality
13 secondary outcomes
Central venous pressure
Time frame: intensive care unit stay, an average of 5 days
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
mortality rate-1
Time frame: 90 days
mortality rate-2
Time frame: 180 days
mortality rate-3
Time frame: 3 years
mortality rate-4
Time frame: 1 year
mortality rate-5
Time frame: 5 years
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 25 Jul 2019.
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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 Central Venous 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 25 Jul 2019. 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2019.