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

NCT05078086 | Completed

• 1 other identifier: 2021-0486
• Study Type: observational
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Blood Management; Cardiac Surgery; Transfusion

Keywords

arterial-venous oxygen difference; Patient blood management

Outcome Measures

Primary Outcomes (1)

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

  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)

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

Secondary Outcomes (13)

• Incidence of any independent component of the primary outcome

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

• Blood product transfusion

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

• Length of stay in ICU

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

• Total length of hospital stay after surgery

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

• Duration of mechanical ventilation after surgery

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

Study Arms (1)

Patients undergoing cardiac surgery with CPB

\>18 y/o patients who undergo cardiac surgery with cardiopulmonary bypass and with a preoperative additive EuroSCORE I≥ 6

Other: No intervention

Interventions

No intervention OTHER

No intervention

Patients undergoing cardiac surgery with CPB

Eligibility Criteria

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

Study Population

Moderate to high risk patients undergoing cardiac surgery with cardiopulmonary bypass (CPB)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

Location

Study Officials

• Min Yan, Doctor

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Anesthesiology, The Second Affiliated Hospital, Zhejiang University School of Medicine

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 14, 2021
• Study Start: October 18, 2021
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

CN (1)