Oxygen Delivery During Cardiopulmonary Bypass And Inflammatory Reaction After Cardiac Surgery

NCT ID: NCT06993467

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 908 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-30
• Study Completion Date: 2025-01-31

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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero, Universitaria Ospedali Riuniti

OTHER

Sponsor Role: lead

Responsible Party

Enrico Squiccimarro

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anthea Hospital

Bari, Italia, Italy

Santa Maria Hospital, GVM Care & Research

Bari, Italia, Italy

Countries

Italy

Other Identifiers

OXY_INFLAMM.01

Identifier Type: -

Identifier Source: org_study_id