Application of Intraoperative Transesophageal Echocardiography Imaging of Vein and CLCVP in Early Prediction and Intervention CSA-AKI

Not Applicable

Completed

• Conditions: Acute Kidney Injury
• Interventions: Combination Product: Controlled low central venous pressure (CLCVP) technology; Drug: Nitroglycerin

• Registration Number: NCT05682716
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

The goal of this clinical trial is to learn about in postoperative acute kidney injury in cardiac surgery. The main questions it aims to answer are:

* Intraoperative Transesophageal Ultrasound Doppler venous imaging can be used to predict the occurrence of cardiac surgery associated acute kidney injury (CSA-AKI ) in the early stage by observing the changes of renal vein, portal vein and hepatic vein blood flow patterns, calculating the renal vein stasis index and portal vein pulsatility index, and evaluating the degree of venous congestion.

* Controlled low central venous pressure (CLCVP) technology can reduce the occurrence of CSA-AKI by reducing venous congestion and increasing renal perfusion pressure.

Participants will receive Transesophageal Ultrasound Doppler during cardiac surgery. If the participant is assigned to the intervention group, if the central venous pressure of the participant is ≥ 10mmHg 30 minutes after the end of cardiopulmonary bypass, he will receive nitroglycerin pumped to apply the controlled low central venous pressure (CLCVP) technology; If participants are assigned to the control group, no intervention measures will be taken.

The researchers will compare the intervention group with the control group to see the occurrence of AKI and AKD after cardiac surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-15
• Primary Completion: 2022-11-29
• Study Completion: 2022-12-27
• Status Verified: 2023-01
• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-01-11
• Last Update Submitted: 2023-01-11
• Study First Posted: 2023-01-12
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

Patients aged above 18 years undergoing coronary artery bypass graft or heart valve surgery under cardiopulmonary bypass.

Exclusion Criteria

1. Patients with CKD history, end-stage renal disease and renal transplantation before operation
2. Used nephrotoxic drugs within two weeks before operation
3. Known Renal Artery Stenosis and Renal Malformations
4. There are contraindications for transesophageal ultrasound Doppler evaluation of esophageal space occupying lesions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Controlled low central venous pressure (CLCVP) technology	Controlled low central venous pressure (CLCVP) technology
Intervention group	Nitroglycerin	Controlled low central venous pressure (CLCVP) technology

Primary Outcome Measures

Name	Time	Method
Level of Serum creatinine	Before operation to 90 days after operation	SCR

Secondary Outcome Measures

Name	Time	Method
Kidney Injury Molecule-1 (KIM-1)	Before operation to 12 hours after operation	Kidney Injury Molecule-1
Neutrophil gelatinase associated lipid transporter (NGAL)	Before operation to 2 hours after operation	Neutrophil gelatinase associated lipid transporter

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China