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OpenTrials
Completed

NCT Number: NCT06993467

Oxygen Delivery During Cardiopulmonary Bypass And Inflammatory Reaction After Cardiac Surgery

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Anthea Hospital, Bari, Italia, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Composite outcome

    Time frame: Up to 30 days

    Composite outcome comprising death, TIA/stroke, renal replacement therapy, bleeding, mechanical circulatory support, or ICU stay >96 hours

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Ospedali Riuniti

Other

Registry information

Acronym: OXYINFLAMM

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 28, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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