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

NCT05682716 | Completed DMC

• 1 other identifier: CT20230104
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury; Acute Kidney Disease; Postoperative complications of cardiac surgery; Transesophageal echocardiography

Outcome Measures

Primary Outcomes (1)

• Level of Serum creatinine

  SCR

  Before operation to 90 days after operation

Secondary Outcomes (2)

• Neutrophil gelatinase associated lipid transporter (NGAL)

  Before operation to 2 hours after operation

• Kidney Injury Molecule-1 (KIM-1)

  Before operation to 12 hours after operation

Study Arms (2)

Intervention group

EXPERIMENTAL

Controlled low central venous pressure (CLCVP) technology

Combination Product: Controlled low central venous pressure (CLCVP) technology; Drug: Nitroglycerin

control group

NO INTERVENTION

Interventions

Controlled low central venous pressure (CLCVP) technology COMBINATION_PRODUCT

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.

Intervention group

Nitroglycerin DRUG

nitroglycerin (0.2-1 ug/kg \* min)

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210012, China

Location

Related 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. 2022 May;128(5):785-795. doi: 10.1016/j.bja.2022.01.032. Epub 2022 Mar 4.

  PMID: 35249707 RESULT

• 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.

  PMID: 33549321 RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Technology; Nitroglycerin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture; Nitro Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 12, 2023
• Study Start: July 15, 2022
• Primary Completion: November 29, 2022
• Study Completion: December 27, 2022
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)