Prevention and Treatment of AKI VEXUS Guided Post Cardiac Surgery

NCT06972082 | Recruiting

• 1 other identifier: 778/12.06.2023
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this clinical trial is to learn if evaluation by ultrasound of venous congestion of liver and kidneys can guide treatment and prevent and treat acute kidney injury post cardiac surgery (CSA-AKI). Participants will: Be evaluated by liver and kidney veins ultrasound (treatment group) or a placebo post CSA-AKI. Fluid management for the treatment group will be based on a score that emerges from this evaluation (Venous Excess Ultrasound Score, VEXUS). Kidney function will be daily monitored and followed-up for 7 days and until discharge. Daily fluid balance and laboratory examination will be performed. Data will be recorded and collected and a statistical analysis will provide the results that will show or not a probable superiority of this evaluation comparing to the usual care.

Conditions

Acute Kidney Injury; Cardiac Surgery Associated - Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Renal function

  Renal function (Creatinine, \[ΔCreatinine, %\]) · Record Urea, Creatinine

  Record Urea, Creatinine (preoperative value, enrollment day, post-operatively: 24hours-, 48hours-, 72hours-, 7th day-, at ICU discharge)

Study Arms (2)

Control

NO INTERVENTION

Standard of care

VEXUS

OTHER

Goal-directed fluid therapy according to VEXUS measurements to minimize AKI

Device: VEXUS

Interventions

VEXUS DEVICE

Goal-directed fluid and drug therapy according to VEXUS measurements to minimize AKI

VEXUS

Eligibility Criteria

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

You may qualify if:

• Patients in the Cardiac Surgery ICU who develop acute kidney injury according to KDIGO criteria, within 48 hours of ICU admission after cardiac surgery
• Elective and non-elective cardiac surgery.

You may not qualify if:

• Patient refusal
• Severe chronic renal failure (GFR\<15 mL/min/m2 or on hemodialysis).
• Critical preoperative condition (severe cardiogenic shock, resuscitated cardiac arrest, support with mechanical circulatory assist devices).
• Liver cirrhosis or inferior vena cava obstruction.
• Pregnancy.
• Morbid obesity (BMI\>40 kg/m2).
• Delirium or other condition that prevents the performance of an ultrasound study.

Sponsors & Collaborators

• Onassis Cardiac Surgery Centre: lead

Study Sites (1)

Onassis Cardiac Surgery Center

Athens, Kallithea, 17674, Greece

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Stavros Dimopoulos, PhD, EDIC

CONTACT

00306973956974; stdimop@gmail.com

Konstantina Kolonia, MD, MSc

CONTACT

00306958261393; kon.kolonia@gmail.com

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: April 28, 2025
• First Posted: May 14, 2025
• Study Start: June 29, 2023
• Primary Completion: June 30, 2025
• Study Completion: October 1, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)