Clinical trial NCT05078086: Study on the Relationship of Arterial-venous Oxygen Difference and Postoperative Complications After Cardiac Surgery.
Official title: Study on the Relationship of Arterial-venous Oxygen Difference and Postoperative Complications After Cardiac Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Blood Management
Cardiac Surgery
Transfusion
Keywords: arterial-venous oxygen difference
Patient blood management
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moderate to high risk patients undergoing cardiac surgery with cardiopulmonary bypass (CPB)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite outcome of mortality and serious morbidity (cardiac, renal, and neurological events)
timeFrame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Secondary outcomes:
measure: Incidence of any independent component of the primary outcome
timeFrame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
measure: Blood product transfusion
timeFrame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
measure: Length of stay in ICU
timeFrame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
measure: Total length of hospital stay after surgery
timeFrame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
measure: Duration of mechanical ventilation after surgery
timeFrame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
measure: Occurrence of low cardiac output after surgery
timeFrame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
measure: Infection
timeFrame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
measure: Gut infarction
timeFrame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
measure: Acute kidney injury
timeFrame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
measure: Seizures
timeFrame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
measure: Delirium
timeFrame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
measure: Encephalopathy
timeFrame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
measure: Reoperation rate
timeFrame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University anesthesiology department
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Min Yan, Doctor
role: PRINCIPAL_INVESTIGATOR
References: