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NCT Number: NCT06991218

Analysis of the Interaction Between Preoperative Lifestyle and Clinical Characteristics of Cardiac Surgery Patients and Perioperative Complications

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

  • Inclusion Criteria:
  • Age ≥ 18 years old.
  • Patients scheduled for elective cardiac surgery.
  • Patients who received medical care at hospital from January 2018 to November 2022.

2.Exclusion Criteria:

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

Treatment and study plan

cardiac surgery

Procedure

Adult patients (age ≥18 years) who underwent cardiac surgery with cardiopulmonary bypass were included.

Primary outcomes

  1. The occurrence of perioperative complications of important organs

    Time frame: Within 30 days after the operation.

    The occurrence of perioperative complications of important organs (including the nervous system, respiratory system, urinary system, etc.)

Secondary outcomes

  1. Acute kidney injury (AKI)

    Time frame: Within 7 days postoperatively.

    AKI was the primary outcome in this study, defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria as serum creatinine increase of ≥0.3 mg/dL within 48 hours postoperatively, or ≥1.5 times baseline creatinine within 7 days after surgery. AKI onset was determined on the first day when diagnostic criteria were met. Furthermore, AKI severity was staged according to following criteria: stage Ⅰ, serum creatinine increase of 0.3-4.0 mg/dL within 48 hours or 1.5-1.9 times baseline creatinine within 7 days postoperatively; stage Ⅱ, 2.0-2.9 times baseline creatinine within 7 days postoperatively; stage Ⅲ, serum creatinine increase >4.0 mg/dL within 48 hours or ≥3 times baseline within 7 days postoperatively.

  2. Acute respiratory distress syndrome

    Time frame: Within 30 days after the operation.

    According to the 2012 Berlin definition, ARDS is classified into mild (PaO2/FiO2≤300mmHg), moderate (PaO2/FiO2≤200mmHg), or severe ARDS (PaO2/FiO2≤200mmHg).

  3. Perioperative stroke

    Time frame: Within 30 days after the operation.

    CT within 30 days after the operation indicated hemorrhagic or ischemic cerebral infarction.

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Acronym: AKI

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 27, 2025
Registry last updated
May 27, 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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