Acute Kidney InjuryAKINCT06991218
Analysis of the Interaction Between Preoperative Lifestyle and Clinical Characteristics of Cardiac Surgery Patients and Perioperative Complications
An observational study of Acute Kidney Injury and Cardiac Surgery, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Cardiac Surgery, Hemoglobin
- What is being tested?
- cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,366 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
About this study
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.
Read the 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.
- Being tested
- cardiac surgery
- Keywords
- acute kidney injury, cardiac surgery, hemoglobin trajectory, Perioperative complications
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac surgeryProcedure or surgery
Adult patients (age ≥18 years) who underwent cardiac surgery with cardiopulmonary bypass were included.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | The subjects of this study were patients aged 18 and above who underwent elective cardiac surgery. Receives: Procedure: cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: Within 30 days after the operation.
Secondary outcomes (3)
Acute kidney injury (AKI)
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.
Measured: Within 7 days postoperatively.
Acute respiratory distress syndrome
According to the 2012 Berlin definition, ARDS is classified into mild (PaO2/FiO2≤300mmHg), moderate (PaO2/FiO2≤200mmHg), or severe ARDS (PaO2/FiO2≤200mmHg).
Measured: Within 30 days after the operation.
Perioperative stroke
CT within 30 days after the operation indicated hemorrhagic or ischemic cerebral infarction.
Measured: Within 30 days after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2025
- Study start1 Dec 2023
- Primary completion1 Jun 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ke-Xuan Liu, Doctor, Principal investigator, Department of Anesthesiology, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991218
- Sponsor's protocol ID
- NFEC-2023-587
- Other IDs
- 2023YFC2506900
- Acronym
- AKI
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 27 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The relevant data need to be kept confidential.
Publications
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.
PubMed 22418007Oprea 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.
PubMed 29098634Section 2: AKI Definition. Kidney Int Suppl (2011). 2012 Mar;2(1):19-36. doi: 10.1038/kisup.2011.32. No abstract available.
PubMed 25018918Cao 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.
PubMed 35946481
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Interaction Between Preoperative Lifestyle and Clinical Characteristics of Cardiac Surgery Patients and Perioperative Complications
- ClinicalTrials.gov ID
- NCT06991218
- Acronym / sponsor ID
- AKI / NFEC-2023-587
- Keywords
- acute kidney injury, cardiac surgery, hemoglobin trajectory, Perioperative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,366 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 27 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Procedure: cardiac surgeryThe subjects of this study were patients aged 18 and above who underwent elective cardiac surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac surgeryAdult patients (age ≥18 years) who underwent cardiac surgery with cardiopulmonary bypass were included. | Procedure or surgery | Study Group |
Primary outcome
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.)
3 secondary outcomes
Acute kidney injury (AKI)
Time frame: Within 7 days postoperatively.
Acute respiratory distress syndrome
Time frame: Within 30 days after the operation.
Perioperative stroke
Time frame: Within 30 days after the operation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2025.
- Background: PubMed 22418007Glance 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.
- Background: PubMed 29098634Oprea 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.
- Background: PubMed 25018918Section 2: AKI Definition. Kidney Int Suppl (2011). 2012 Mar;2(1):19-36. doi: 10.1038/kisup.2011.32. No abstract available.
- Background: PubMed 35946481Cao 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.
- Definition and classification of AKI.Link provided by the sponsor.
- Individual participant dataSharing planned: No. The relevant data need to be kept confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ke-Xuan Liu, Doctor principal investigator
Department of Anesthesiology, Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Cardiac Surgery, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of perioperative complications of important organs (time frame: Within 30 days after the operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06991218, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2025.