Cardiopulmonary BypassOXYINFLAMMNCT06993467
Oxygen Delivery During Cardiopulmonary Bypass And Inflammatory Reaction After Cardiac Surgery
An observational study of Cardiopulmonary Bypass and Cardiac Surgery, run by Azienda Ospedaliero, Universitaria Ospedali Riuniti at 2 sites in Italy.
Trial summary
Cardiac surgery, especially when involving cardiopulmonary bypass (CPB), has long been associated with a systemic inflammatory response that can lead to a range of complications, from mild symptoms to severe organ dysfunction, and mortality. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiopulmonary Bypass, Cardiac Surgery, Systemic Inflammatory Response Syndrome (SIRS)
- How many people
- 908 participants
- Where
- 2 sitesItaly
- Study dates
- 30 Oct 2023to 31 Jan 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult cardiac surgery patients undergoing elective cardiopulmonary bypass-assisted procedures
Who may be able to join
- Adult patients (18-90 years)
- Elective surgery
- CPB-assisted
Who cannot join
- Age < 18 or > 90 years
- Infective endocarditis
- Hypothermia during surgery (<34°C)
- Emergency surgery
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Anthea Hospital
Bari, Italia
Santa Maria Hospital, GVM Care & Research
Bari, Italia
About this study
Cardiac surgery, especially when involving cardiopulmonary bypass (CPB), has long been associated with a systemic inflammatory response that can lead to a range of complications, from mild symptoms to severe organ dysfunction, and mortality. The exact mechanisms behind this response remain a topic of extensive research, but it's clear that the body's reaction to the extracorporeal circulation, combined with surgical trauma, plays a significant role. Factors such as genomics, age, specific preoperative conditions, and the duration of operations have been associated with significant clinical responses.
A pivotal insight into this response comes from recent genome-wide transcriptional analyses. Perioperative ischemia and ischemia-reperfusion injury (IRI) have been suggested as hub-nodes in a hierarchic structure evaluating the response to cardiac surgery. This suggests that IRI isn't just a side effect of the surgery but might be a central player in the body's inflammatory response. The role of perioperative ischemia and its potential as a significant contributor to the postoperative inflammatory response cannot be understated. This study aims to delve deeper into the role of oxygen delivery and its implications in the systemic inflammatory response post- cardiac surgery.
- Keywords
- cardiopulmonary bypass, oxygen delivery, systemic inflammatory reaction syndrome, cardiac surgery
- Medical subject headings
- Systemic Inflammatory Response Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
SIRS
Systemic Inflammatory Reaction Syndrome (SIRS) as per the 1991 American College of Chest Physicians/Society of Critical Care Medicine criteria
Measured: 12 hours after surgery
Secondary outcomes (1)
Composite outcome
Composite outcome comprising death, TIA/stroke, renal replacement therapy, bleeding, mechanical circulatory support, or ICU stay >96 hours
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start30 Oct 2023
- Primary completion31 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 908 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Ospedali Riuniti
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Squiccimarro, Azienda Ospedaliero, Universitaria Ospedali Riuniti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993467
- Sponsor's protocol ID
- OXY_INFLAMM.01
- Acronym
- OXYINFLAMM
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Delivery During Cardiopulmonary Bypass And Inflammatory Reaction After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06993467
- Acronym / sponsor ID
- OXYINFLAMM / OXY_INFLAMM.01
- Keywords
- cardiopulmonary bypass, oxygen delivery, systemic inflammatory reaction syndrome, cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 908 participants (actual)
- Lead sponsor
- Azienda Ospedaliero, Universitaria Ospedali RiunitiUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 28 May 2025 (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.
Cardiac surgery, especially when involving cardiopulmonary bypass (CPB), has long been associated with a systemic inflammatory response that can lead to a range of complications, from mild symptoms to severe organ dysfunction, and mortality. The exact mechanisms behind this response remain a topic of extensive research, but it's clear that the body's reaction to the extracorporeal circulation, combined with surgical trauma, plays a significant role. Factors such as genomics, age, specific preoperative conditions, and the duration of operations have been associated with significant clinical responses.
A pivotal insight into this response comes from recent genome-wide transcriptional analyses. Perioperative ischemia and ischemia-reperfusion injury (IRI) have been suggested as hub-nodes in a hierarchic structure evaluating the response to cardiac surgery. This suggests that IRI isn't just a side effect of the surgery but might be a central player in the body's inflammatory response. The role of perioperative ischemia and its potential as a significant contributor to the postoperative inflammatory response cannot be understated. This study aims to delve deeper into the role of oxygen delivery and its implications in the systemic inflammatory response post- cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult cardiac surgery patients undergoing elective cardiopulmonary bypass-assisted procedures
Key inclusion criteria (3 listed)
- Adult patients (18-90 years)
- Elective surgery
- CPB-assisted
Key exclusion criteria (4 listed)
- Age < 18 or > 90 years
- Infective endocarditis
- Hypothermia during surgery (<34°C)
- Emergency surgery
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
SIRS
Time frame: 12 hours after surgery
Systemic Inflammatory Reaction Syndrome (SIRS) as per the 1991 American College of Chest Physicians/Society of Critical Care Medicine criteria
1 secondary outcome
Composite outcome
Time frame: Up to 30 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 28 May 2025.
- Individual participant dataSharing planned: Undecided
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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 Cardiopulmonary Bypass and Cardiac Surgery, run by Azienda Ospedaliero, Universitaria Ospedali Riuniti 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 4 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 28 May 2025. 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?
SIRS (time frame: 12 hours after surgery). 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 28 May 2025.