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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Combination product: Controlled low central venous pressure (CLCVP) technology; Drug: Nitroglycerin

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210012
      • Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: Intervention group; Controlled low central venous pressure (CLCVP) technology	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Serum creatinine	SCR	Before operation to 90 days after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neutrophil gelatinase associated lipid transporter (NGAL)	Neutrophil gelatinase associated lipid transporter	Before operation to 2 hours after operation
Kidney Injury Molecule-1 (KIM-1)	Kidney Injury Molecule-1	Before operation to 12 hours after operation

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Publications and helpful links

General Publications

• 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. 2022 May;128(5):785-795. doi: 10.1016/j.bja.2022.01.032. Epub 2022 Mar 4.
• 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;126(3):599-607. doi: 10.1016/j.bja.2020.12.028. Epub 2021 Feb 4.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): November 29, 2022
• Study Completion (Actual): December 27, 2022

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Acute Kidney Injury; Transesophageal echocardiography; Acute Kidney Disease; Postoperative complications of cardiac surgery
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury; Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: CT20230104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No