- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05139108
TEE Monitoring and the Incidence of Postoperative Acute Kidney Injury in Coronary Artery Bypass Grafting
The Association Between Transesophageal Echocardiography Monitoring and the Incidence of Postoperative Acute Kidney Injury in Coronary Artery Bypass Grafting:a Prospective Observational Study
TEE has a definite effect on the evaluation of cardiac structure and function in perioperative cardiac surgery. However, in CABG, previous studies on TEE mainly focused on whether to change the surgical plan rather than improve the clinical prognosis. There are few related studies on the evaluation of prognosis, and these studies have low efficacy and inconsistent conclusions. Acute kidney injury is the most common complication of CABG surgery and is independently associated with hospitalization and long-term mortality. In CABG patients, acute kidney injury, in addition to operation-related factors, is closely related to renal perfusion. These patients often exist serious coronary multivessel lesions and right heart dysfunction, which can cause the system obstacle of regurgitation of the inferior vena cava and kidney blood stasis, while the inappropriate rehydration fluid overload will affect kidney blood perfusion, which may be one of the reasons for the kidney injury. Therefore, appropriate volume status plays an important role in maintaining right heart function and renal perfusion. What indicators can the investigators use to effectively evaluate the patient's volume status and monitor the patient's right heart function?
In recent years, ultrasound has been used as an effective tool to assess patient volume status , right heart function, and to guide patient fluid management. Many studies have confirmed that the respiratory variability of inferior vena cava diameter (ΔIVC) measured by TTE has a good correlation with the volume status of patients on mechanical ventilation, which has a high diagnostic value for predicting the fluid responsiveness and guiding fluid management.However, no study has been reported using TEE measurements of ΔIVC to assess volume status and guide fluid management in patients undergoing cardiac bypass surgery. Previous studies have confirmed that TAPSE measured by TTE is independently associated with AKI in ICU patients and can predict the occurrence of AKI in such patients. However, TAPSE monitored by TEE have not been reported in this regard. Can ΔIVC and TAPSE predict the incidence of AKI and major cardiovascular and cerebrovascular adverse events in CABG patients?
Therefore, the investigators designed this observational study to further scientifically confirm the validity and guiding significance of ΔIVC and TAPSE in CABG, so as to protect and improve patients' renal function , reduce postoperative mortality and improve the clinical prognosis.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: binghua liu, master
- Phone Number: 18560293562
- Email: liubinghua042525@126.com
Study Locations
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Shandong
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Jinan, Shandong, China, 250000
- Recruiting
- Shandong Provincial Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
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Contact:
- wang yuelan, PH.D
- Phone Number: 15953105780
- Email: wyldgf@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged ≥18 years;
- Patients undergoing elective isolated coronary artery bypass surgery (with or without bypass);
- In line with ethics, the patients volunteered to take the test and signed the informed consent for the clinical study;
Exclusion Criteria:
- Patients with severe renal insufficiency before surgery;
- Preoperative patients with moderate or more than moderate valvular lesions required surgery;
- Diabetic patients with a history of serious diabetic complications (diabetic ketoacidosis, hyperosmolar coma, various infections, macrovascular lesions, diabetic nephropathy);
- Patients with TEE contraindications
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the incidence of postoperative acute kidney injury
Time Frame: Within 7 days after surgery
|
acute kidney injury after cardiac surgery
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Within 7 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the incidence of major postoperative cardiovascular and cerebrovascular adverse events
Time Frame: Within 30 days after surgery
|
major postoperative cardiovascular and cerebrovascular adverse events after cardiac surgery
|
Within 30 days after surgery
|
the incidence of pulmonary complications
Time Frame: Within 30 days after surgery
|
pulmonary complications included pulmonary infection,pulmonary atelectasis, acute lung injury, respiratory failure after cardiac surgery
|
Within 30 days after surgery
|
ICU endotracheal intubation time
Time Frame: Within 30 days after surgery
|
ICU endotracheal intubation time
|
Within 30 days after surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: yuelan Wang, PH.D, Qianfoshan Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QianfoshanH TEE-AKI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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