Skip to content

Oxygen Delivery During Cardiopulmonary Bypass And Inflammatory Reaction After Cardiac Surgery

Oxygen Delivery During Cardiopulmonary Bypass And Inflammatory Reaction After Cardiac Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06993467
Acronym
OXYINFLAMM
Enrollment
908
Registered
2025-05-28
Start date
2023-10-30
Completion date
2025-01-31
Last updated
2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Cardiopulmonary Bypass, Systemic Inflammatory Response Syndrome (SIRS)

Keywords

cardiopulmonary bypass, oxygen delivery, systemic inflammatory reaction syndrome, cardiac surgery

Brief 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. 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.

Interventions

None listed

Sponsors

Azienda Ospedaliero, Universitaria Ospedali Riuniti
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Adult patients (18-90 years) * Elective surgery * CPB-assisted

Exclusion criteria

* Age \< 18 or \> 90 years * Infective endocarditis * Hypothermia during surgery (\<34°C) * Emergency surgery

Design outcomes

Primary

MeasureTime frameDescription
SIRS12 hours after surgerySystemic Inflammatory Reaction Syndrome (SIRS) as per the 1991 American College of Chest Physicians/Society of Critical Care Medicine criteria

Secondary

MeasureTime frameDescription
Composite outcomeUp to 30 daysComposite outcome comprising death, TIA/stroke, renal replacement therapy, bleeding, mechanical circulatory support, or ICU stay \>96 hours

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026