Heart DiseasesNCT03591029
Evaluation of PCO2 and PO2 Values in the Pulmonary Artery and Superior Vena Cava
An observational study of Heart Diseases, run by Catholic University of the Sacred Heart at 2 sites in Italy.
Trial summary
The study is about comparing blood samples obtained from the superior vena cava and the pulmonary artery. The investigators will compare the values of PCO2 and PO2 from these two sites, in order to see if exists a PCO2 gap and a PO2 gap, different from zero. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases
- What is being tested?
- blood samples
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 19 Jul 2018to 24 Jul 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: Will be enrolled adult patients only , eligible for cardiac surgery (CABG, valvular replacement, aortic surgery) with extra corporeal circulation.
Who may be able to join
- age > 18 years
- patient undergoing cardiac surgery with extracorporeal circulation
- hemodynamic monitoring with a central venous catheter and a Swan Ganz catheter placed in the internal left giugulare vein
Who cannot join
- severe tricuspid insufficiency
- EF < 50%
- SOFA score >1 in at least one of all the criteria
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
catholic University of the sacred Heart
Rome, 00168
Francesca Bevilacqua
Rome, 00168
About this study
Official title: Evaluation of PCO2 and PO2 Values in the Pulmonary Artery and in the Superior Vena Cava: Relationship With Cardiac Output, Hematocrit and Post Operative Organ Dysfunction
The study is about comparing blood samples obtained from the superior vena cava and the pulmonary artery. The investigators will compare the values of PCO2 and PO2 from these two sites, in order to see if exists a PCO2 gap and a PO2 gap, different from zero. Moreover the investigators want to find out if these gaps are related with changes in the cardiac output, the hematocrit or if they can predict post operative dysfunctions.
Blood samples will be taken at six different times as scheduled by the protocol. Along with the two venous blood samples, an arterial blood sample will be taken too, from a radial of femoral artery catheter.
- Conditions
- Heart Diseases
- Being tested
- blood samples
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesOther
blood samples will be obtained from the superior vena cava (via centra venous catheter), from the pulmonary artery (via Swan Ganz catheter), and from a radial or femoral artery catheter
What is being measured
The primary outcome is the main question the study is designed to answer.
PCO2 gap changes
See if exists a PCO2 pa-svc gap different from zero in patients undergoing cardiac surgery
Measured: two days
PO2 gap changes
See if exists a PCO2 pa-svc gap different from zero in patients undergoing cardiac surgery
Measured: two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start19 Jul 2018
- Primary completion23 Jul 2019
- Study completion24 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franco Cavaliere, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591029
- Sponsor's protocol ID
- Polm01
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2018
- Last updated
- 31 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PCO2 and PO2 Values in the Pulmonary Artery and in the Superior Vena Cava: Relationship With Cardiac Output, Hematocrit and Post Operative Organ Dysfunction
- ClinicalTrials.gov ID
- NCT03591029
- Acronym / sponsor ID
- Polm01
- Conditions
- Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 23 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 18 Jul 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.
The study is about comparing blood samples obtained from the superior vena cava and the pulmonary artery. The investigators will compare the values of PCO2 and PO2 from these two sites, in order to see if exists a PCO2 gap and a PO2 gap, different from zero. Moreover the investigators want to find out if these gaps are related with changes in the cardiac output, the hematocrit or if they can predict post operative dysfunctions.
Blood samples will be taken at six different times as scheduled by the protocol. Along with the two venous blood samples, an arterial blood sample will be taken too, from a radial of femoral artery catheter.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Will be enrolled adult patients only , eligible for cardiac surgery (CABG, valvular replacement, aortic surgery) with extra corporeal circulation.
Key inclusion criteria (3 listed)
- age > 18 years
- patient undergoing cardiac surgery with extracorporeal circulation
- hemodynamic monitoring with a central venous catheter and a Swan Ganz catheter placed in the internal left giugulare vein
Key exclusion criteria (3 listed)
- severe tricuspid insufficiency
- EF < 50%
- SOFA score >1 in at least one of all the criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplesblood samples will be obtained from the superior vena cava (via centra venous catheter), from the pulmonary artery (via Swan Ganz catheter), and from a radial or femoral artery catheter | Other | – |
Primary outcome
PCO2 gap changes
Time frame: two days
See if exists a PCO2 pa-svc gap different from zero in patients undergoing cardiac surgery
PO2 gap changes
Time frame: two days
See if exists a PCO2 pa-svc gap different from zero in patients undergoing cardiac surgery
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 31 Jul 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases, run by Catholic University of the Sacred Heart at 2 sites in Italy.
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 3 inclusion and 3 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 31 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 2 sites in Italy. 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?
PCO2 gap changes (time frame: two 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?
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 31 Jul 2019.