Clinical trial NCT06991218: Analysis of the Interaction Between Preoperative Lifestyle and Clinical Characteristics of Cardiac Surgery Patients and Perioperative Complications
Official title: Analysis of the Interaction Between Preoperative Lifestyle and Clinical Characteristics of Cardiac Surgery Patients and Perioperative Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Cardiac Surgery
Hemoglobin
Perioperative Complications
Keywords: acute kidney injury
cardiac surgery
hemoglobin trajectory
Perioperative complications
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2025-05-27
Enrollment: 1366
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients (age ≥18 years) who underwent cardiac surgery with cardiopulmonary bypass in a large-scale comprehensive hospital between January 1, 2019 and October 31, 2023, were included.

Brief summary: Each year, over four million patients die within 30 days after surgery, accounting for 7.7% of global deaths. Due to its unique nature, cardiac surgery carries a significantly higher risk of perioperative complications and long-term mortality compared to non-cardiac surgeries. Therefore, the identification, management, and prevention of perioperative complications in cardiac surgery have long been a clinical focus. Common manifestations of perioperative organ injury include neurological complications, acute kidney injury, respiratory failure, gastrointestinal dysfunction, and liver injury. This study aims to explore the association between preoperative lifestyle and postoperative complications in cardiac surgery, as well as their interaction with clinical characteristics, in order to facilitate the prediction and prevention of perioperative complications. This retrospective cohort study plans to include adult patients undergoing elective cardiac surgery as the object of study. Different preoperative lifestyle habits will be considered as exposure factors to investigate the relationships between these exposure factors and the occurrence of major organ complications after cardiac surgery.

Detailed description: The risk of death and major complications in patients undergoing general anesthesia is less than 1%, thanks to the implementation of clinical practice guidelines and checklists, as well as advancements in training, medications, monitoring devices, and equipment. Consequently, the safety of anesthesia has steadily improved over the past century. However, a recent assessment in Europe and the United States indicates that the overall postoperative mortality rate remains higher than expected and is considered the third leading cause of death globally, following ischemic heart disease and cancer. This statistical result should be noted, as perioperative deaths are multifactorial and it is challenging to clearly distinguish between surgery-related deaths and those attributed to preoperative comorbidities. Each year, over four million patients die within 30 days after surgery, accounting for 7.7% of global deaths.

Due to its unique characteristics, cardiac surgery carries a significantly higher risk of perioperative complications and long-term mortality compared to non-cardiac surgeries. Therefore, the identification, management, and prevention of perioperative complications in cardiac surgery have long been a clinical focus. Integrating surgical and patient-related risk factors in a personalized manner before, during, and after surgery can improve patient outcomes, as exemplified by Enhanced Recovery After Surgery (ERAS) protocols. However, despite improvements in all preventive measures, acute organ injury remains a common complication and a significant risk factor for morbidity and mortality in cardiac surgery patients. Common manifestations of perioperative organ injury include neurological complications, acute kidney injury (AKI), respiratory failure, gastrointestinal dysfunction, and liver injury.

Although much beneficial work has been done regarding the prevention and identification of perioperative complications in cardiac surgery, there is currently limited research on the impact of patients' preoperative medical history, personal history, and comorbidities on the occurrence and prediction of perioperative complications in cardiac surgery. This study focuses on exploring the association between preoperative lifestyle and postoperative complications in cardiac surgery. Additionally, the study will examine the interaction between preoperative laboratory tests and examinations, intraoperative anesthetic medication and vital sign monitoring, and preoperative lifestyle factors.

Eligibility criteria: 1. Inclusion Criteria:

1. Age ≥ 18 years old.
2. Patients scheduled for elective cardiac surgery.
3. Patients who received medical care at hospital from January 2018 to November 2022.

2.Exclusion Criteria:

1. Pregnant women.
2. Patients whose preoperative examinations indicated they had already met the diagnostic criteria for acute kidney injury (AKI) or acute respiratory distress syndrome (ARDS).
3. Patients with severe preoperative abnormalities in liver or kidney function.
4. Patients with more than 10% missing data in their basic clinical information.
5. Patients with mental disorders.

Primary outcomes:
measure: The occurrence of perioperative complications of important organs
timeFrame: Within 30 days after the operation.
Secondary outcomes:
measure: Acute kidney injury (AKI)
timeFrame: Within 7 days postoperatively.
measure: Acute respiratory distress syndrome
timeFrame: Within 30 days after the operation.
measure: Perioperative stroke
timeFrame: Within 30 days after the operation.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Department of Anesthesiology, Nanfang Hospital, Southern Medical University
name: Ke-Xuan Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Glance LG, Lustik SJ, Hannan EL, Osler TM, Mukamel DB, Qian F, Dick AW. The Surgical Mortality Probability Model: derivation and validation of a simple risk prediction rule for noncardiac surgery. Ann Surg. 2012 Apr;255(4):696-702. doi: 10.1097/SLA.0b013e31824b45af.
citation: Oprea AD, Del Rio JM, Cooter M, Green CL, Karhausen JA, Nailer P, Guinn NR, Podgoreanu MV, Stafford-Smith M, Schroder JN, Fontes ML, Kertai MD. Pre- and postoperative anemia, acute kidney injury, and mortality after coronary artery bypass grafting surgery: a retrospective observational study. Can J Anaesth. 2018 Jan;65(1):46-59. doi: 10.1007/s12630-017-0991-0. Epub 2017 Nov 2.
citation: Section 2: AKI Definition. Kidney Int Suppl (2011). 2012 Mar;2(1):19-36. doi: 10.1038/kisup.2011.32. No abstract available.
citation: Cao L, Ru W, Hu C, Shen Y. Interaction of hemoglobin, transfusion, and acute kidney injury in patients undergoing cardiopulmonary bypass: a group-based trajectory analysis. Ren Fail. 2022 Dec;44(1):1368-1375. doi: 10.1080/0886022X.2022.2108840.