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NCT Number: NCT05078086

Study on the Relationship of Arterial-venous Oxygen Difference and Postoperative Complications After Cardiac Surgery.

Avoidance of unnecessary blood transfusions has always been a focus of clinical research. The rate of perioperative red blood cell transfusion in patients undergoing cardiac surgery under cardiopulmonary bypass reaches between 50-70%, and the intraoperative red blood cell transfusion rate is 30-50%. Regarding whether and when to perform a blood transfusion, it is necessary to comprehensively consider the benefits and risks brought by blood transfusion.

Previous studies on blood transfusion strategies have mainly focused on the hemoglobin threshold, but the hemoglobin level does not fully reflect the level of tissue oxygenation. Mixed venous blood oxygen saturation has been widely studied as a valuable indicator reflecting the balance of oxygen delivery and oxygen consumption. But due to the difficulty of placing a pulmonary artery floating catheter for monitoring, its clinical application is limited. Central venous oxygen saturation requires only a small collection of blood samples, which can reflect the oxygen saturation of the superior vena cava, and studies have shown that it can effectively guide the blood transfusion of patients undergoing cardiac surgery. Existing studies have shown that in critically ill patients, the use of arterial-venous oxygen difference > 3.7 mL as an indicator to guide blood transfusion can lead to a higher 90-day survival rate. However, the relationship between the arterial-venous oxygen difference and the incidence of adverse events in cardiac surgery patients under CPB remains unclear. Whether increasing the arterial-venous oxygen difference during surgery can reduce the incidence of postoperative adverse events remains to be clarified.

This study intends to collect intraoperative arterial blood and central venous blood samples from cardiac surgery patients undergoing CPB, and analyze the relationship between arterial-venous oxygen difference and the incidence of postoperative adverse events.

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Key information

Conditions

Patient Blood Management Cardiac Surgery Transfusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

About this study

The >18 y/o patients who undergo cardiac surgery with cardiopulmonary bypass and with a preoperative additive EuroSCORE I≥ 6 are enrolled. Blood samples will be collected through arteries and central venous at the following intraoperative time points: before CPB, during CPB, and after CPB. The observation will end by hospital discharge or 28 days after surgery, whichever came first. The follow-up will continue for one year after surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Over 18 years old
  • Cardiovascular surgery patients with cardiopulmonary bypass
  • Preoperative EuroSCORE I≥6（European System for Cardiac Operative Risk Evaluation)
  • Obtained informed consent

Exclusion criteria

  • Patients who cannot accept blood products
  • Patients who refuse to accept transfusion
  • Patients with autologous blood reserve before surgery
  • Patients who are going to receive heart transplantation or have undergone heart transplantation
  • Patients who have undergone ventricular assist device implantation surgery
  • Patients who refuse to participate in this trial

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Composite outcome of mortality and serious morbidity (cardiac, renal, and neurological events)

    Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first

    Composite incidence of any one of the following events occurring during the hospitalization : (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit (stroke)

Secondary outcomes

  1. Incidence of any independent component of the primary outcome

    Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first

    Incidence of any independent component of the primary outcome (all-cause mortality, myocardial infarction, new renal failure requiring dialysis, and new focal neurological deficit (stroke))

  2. Blood product transfusion

    Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first

    Time, category, and volume of blood product transfusion

  3. Length of stay in ICU

    Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first

    Length of stay in ICU after surgery

  4. Total length of hospital stay after surgery

    Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first

    Total length of hospital stay after surgery

  5. Duration of mechanical ventilation after surgery

    Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first

    Total length of hospital stay after surgery

  6. Occurrence of low cardiac output after surgery

    Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first

    Need for two or more inotropes for 24 hours or more, intra-aortic balloon pump postoperatively or ventricular assist device

  7. Infection

    Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first

    Infection will be defined as septic shock with positive blood cultures; pneumonia defined as autopsy diagnosis or roentgenographic infiltrate and at least two of the following three criteria: fever, leukocytosis, and positive sputum culture; and/or deep sternal or leg wound infection requiring intravenous antibiotics and/or surgical debridement

  8. Gut infarction

    Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first

    confirmed by imaging, autopsy, or through surgical means

  9. Acute kidney injury

    Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first

    AKI defined by the KDIGO

  10. Seizures

    Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first

    Defined as generalized or focal tonic-clonic movements consistent with seizure; or EEG demonstrating epileptiform discharges; or diagnosis of seizures by neurologist or neurosurgeon consultation

  11. Delirium

    Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first

    Based on one of the following criteria: CAM-ICU/ CAM (even on 1 occasion) or ICDSC > 3 or more than one dose of haloperidol or similar antipsychotic drug or documented delirium by neurologist or neurosurgeon or psychiatrist consultation

  12. Encephalopathy

    Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first

    Defined as unexpected delayed awakening or severely altered mental status (unconscious despite no sedative medication for more than 5 days), or encephalopathy documented by neurologist or neurosurgeon or psychiatrist consultation

  13. Reoperation rate

    Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first

    The rate of reoperation

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2021
Registry last updated
Jan 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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