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

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Controlled low central venous pressure (CLCVP) technology
Nitroglycerin
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring Acute Kidney Injury, Acute Kidney Disease, Postoperative complications of cardiac surgery, Transesophageal echocardiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nanjing First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

control group

Arm Description

Controlled low central venous pressure (CLCVP) technology

Outcomes

Primary Outcome Measures

Level of Serum creatinine
SCR

Secondary Outcome Measures

Neutrophil gelatinase associated lipid transporter (NGAL)
Neutrophil gelatinase associated lipid transporter
Kidney Injury Molecule-1 (KIM-1)
Kidney Injury Molecule-1

Full Information

First Posted
January 4, 2023
Last Updated
January 11, 2023
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05682716
Brief Title
Application of Intraoperative Transesophageal Echocardiography Imaging of Vein and CLCVP in Early Prediction and Intervention CSA-AKI
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
November 29, 2022 (Actual)
Study Completion Date
December 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Acute Kidney Injury, Acute Kidney Disease, Postoperative complications of cardiac surgery, Transesophageal echocardiography

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Controlled low central venous pressure (CLCVP) technology
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Combination Product
Intervention Name(s)
Controlled low central venous pressure (CLCVP) technology
Intervention Description
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 Type
Drug
Intervention Name(s)
Nitroglycerin
Intervention Description
nitroglycerin (0.2-1 ug/kg * min)
Primary Outcome Measure Information:
Title
Level of Serum creatinine
Description
SCR
Time Frame
Before operation to 90 days after operation
Secondary Outcome Measure Information:
Title
Neutrophil gelatinase associated lipid transporter (NGAL)
Description
Neutrophil gelatinase associated lipid transporter
Time Frame
Before operation to 2 hours after operation
Title
Kidney Injury Molecule-1 (KIM-1)
Description
Kidney Injury Molecule-1
Time Frame
Before operation to 12 hours after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged above 18 years undergoing coronary artery bypass graft or heart valve surgery under cardiopulmonary bypass. Exclusion Criteria: 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
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210012
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35249707
Citation
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.
Results Reference
result
PubMed Identifier
33549321
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;126(3):599-607. doi: 10.1016/j.bja.2020.12.028. Epub 2021 Feb 4.
Results Reference
result

Learn more about this trial

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

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