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

Acute Kidney Injury Clinical Trial

Official title:

Application of Intraoperative Transesophageal Echocardiography Imaging of Vein and Controlled Low Central Venous Pressure in Early Prediction and Intervention of Acute Renal Injury Associated With Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05682716
• Other study ID #: CT20230104
• Status: Completed
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: December 27, 2022

Study information

• Verified date: January 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: December 27, 2022
• Est. primary completion date: November 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Combination Product:
• Controlled low central venous pressure (CLCVP) technology
Controlled low central venous pressure (CLCVP) technology: after cardiopulmonary bypass, pumping nitroglycerin (0.2-1 ug/kg * min) and other methods until the end of surgery to maintain the central venous pressure below 10 mmHg.

Drug:
• Nitroglycerin
nitroglycerin (0.2-1 ug/kg * min)

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Chen L, Hong L, Ma A, Chen Y, Xiao Y, Jiang F, Huang R, Zhang C, Bu X, Ge Y, Zhou J. Intraoperative venous congestion rather than hypotension is associated with acute adverse kidney events after cardiac surgery: a retrospective cohort study. Br J Anaesth. — View Citation

Lopez MG, Shotwell MS, Morse J, Liang Y, Wanderer JP, Absi TS, Balsara KR, Levack MM, Shah AS, Hernandez A, Billings FT 4th. Intraoperative venous congestion and acute kidney injury in cardiac surgery: an observational cohort study. Br J Anaesth. 2021 Mar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Serum creatinine	SCR	Before operation to 90 days after operation
Secondary	Neutrophil gelatinase associated lipid transporter (NGAL)	Neutrophil gelatinase associated lipid transporter	Before operation to 2 hours after operation
Secondary	Kidney Injury Molecule-1 (KIM-1)	Kidney Injury Molecule-1	Before operation to 12 hours after operation