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

NCT ID: NCT05682716

Last Updated: 2023-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2022-12-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Kidney Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

Controlled low central venous pressure (CLCVP) technology

Group Type EXPERIMENTAL

Controlled low central venous pressure (CLCVP) technology

Intervention Type 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.

Nitroglycerin

Intervention Type DRUG

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

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type COMBINATION_PRODUCT

Nitroglycerin

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 35249707 (View on PubMed)

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.

Reference Type RESULT
PMID: 33549321 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CT20230104

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.