Oxygen Delivery During Cardiopulmonary Bypass And Inflammatory Reaction After Cardiac Surgery

NCT06993467 | Completed

• 1 other identifier: OXY_INFLAMM.01
• Study Type: observational
• Target: 908
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• SIRS

  Systemic Inflammatory Reaction Syndrome (SIRS) as per the 1991 American College of Chest Physicians/Society of Critical Care Medicine criteria

  12 hours after surgery

Secondary Outcomes (1)

• Composite outcome

  Up to 30 days

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult cardiac surgery patients undergoing elective cardiopulmonary bypass-assisted procedures

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Ospedali Riuniti: lead

Study Sites (2)

Anthea Hospital

Bari, Italia, Italy

Location

Santa Maria Hospital, GVM Care & Research

Bari, Italia, Italy

Location

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 28, 2025
• Study Start: October 30, 2023
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

IT (2)