An observational study in Cardiopulmonary Bypass, Cardiac Surgery and Systemic Inflammatory Response Syndrome (SIRS), sponsored by Azienda Ospedaliero, Universitaria Ospedali Riuniti. Completed at 2 sites in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Azienda Ospedaliero, Universitaria Ospedali Riuniti · Observational
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.
195 studies on the registry are indexed under Systemic Inflammatory Response Syndrome; 24 are open to participants now.
This study's enrollment of 908 is above the median of 134 across 94 observational studies indexed under Systemic Inflammatory Response Syndrome.
Browse Systemic Inflammatory Response Syndrome studies →Azienda Ospedaliero, Universitaria Ospedali Riuniti is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult cardiac surgery patients undergoing elective cardiopulmonary bypass-assisted procedures
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Exclusion Criteria:
SIRS
Systemic Inflammatory Reaction Syndrome (SIRS) as per the 1991 American College of Chest Physicians/Society of Critical Care Medicine criteria
Time frame: 12 hours after surgery
Composite outcome
Composite outcome comprising death, TIA/stroke, renal replacement therapy, bleeding, mechanical circulatory support, or ICU stay \>96 hours
Time frame: Up to 30 days
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Oct 2023 to primary completion in Dec 2024, 14 months.
Of 42 non-industry observational studies under Systemic Inflammatory Response Syndrome, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 55. This study's 14 months is below that.
Counting every sponsor, half of 47 studies reached it within 31 months; a quarter within 14 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Systemic Inflammatory Response Syndrome →
Azienda Ospedaliero, Universitaria Ospedali Riuniti