NCT06991218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,366

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2025

Completed
Last Updated

May 27, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

May 19, 2025

Last Update Submit

May 19, 2025

Conditions

Keywords

acute kidney injurycardiac surgeryhemoglobin trajectoryPerioperative complications

Outcome Measures

Primary Outcomes (1)

  • The occurrence of perioperative complications of important organs

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

    Within 30 days after the operation.

Secondary Outcomes (3)

  • Acute kidney injury (AKI)

    Within 7 days postoperatively.

  • Acute respiratory distress syndrome

    Within 30 days after the operation.

  • Perioperative stroke

    Within 30 days after the operation.

Study Arms (1)

Study Group

The subjects of this study were patients aged 18 and above who underwent elective cardiac surgery.

Procedure: cardiac surgery

Interventions

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

Study Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Related Publications (4)

  • 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.

    PMID: 22418007BACKGROUND
  • 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.

    PMID: 29098634BACKGROUND
  • Section 2: AKI Definition. Kidney Int Suppl (2011). 2012 Mar;2(1):19-36. doi: 10.1038/kisup.2011.32. No abstract available.

    PMID: 25018918BACKGROUND
  • 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.

    PMID: 35946481BACKGROUND

Related Links

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Ke-Xuan Liu, Doctor

    Department of Anesthesiology, Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2025

First Posted

May 27, 2025

Study Start

December 1, 2023

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

May 27, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

The relevant data need to be kept confidential.

Locations