Prediction of Acute Kidney Injury in Patients With Sepsis Using Venous Excess Ultrasound Score

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis and septic shock are major healthcare problems, killing between one in three and one in six of those they affect. organ dysfunction can be represented by the Sequential Organ Failure Assessment (SOFA) score of 2 points or more (respiratory rate of 22/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or less), which is associated with an in- hospital mortality greater than 10%.

Septic shock is defined as a subset of sepsis in which profound circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone. Patients with septic shock can be clinically identified by a vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (>18 mg/dL) in the absence of hypovolemia. This combination is associated with hospital mortality rates greater than 40%.

Study Overview

• Status: Recruiting
• Conditions: Intensive Care Unit
• Intervention / Treatment: Radiation: Venous Excess Ultrasound Score

Detailed Description

All patients with two out of four of Systemic Inflammatory Response Syndrome (SIRS) criteria (heart rate greater than 90, respiratory rate greater than 20, temperature greater or equal to 38 ⁰ C or less than 36⁰ C, altered mental state) and suspected infection and one of the following risk factors ( Age greater than 65 years, Recent surgery Immunocompromised AIDS, chemotherapy, neutropenia, diabetes, renal failure, hepatic failure, cancer, alcoholism)should be considered at risk of sepsis according to emergency department sepsis guidelines 2022.

The VExUS score ranges from Grades 0-3. In Grade 0, a non- dilated IVC (< 2 cm) indicates that no congestion is present. In Grades 1- 3, the IVC diameter is > 2 cm. In Grade 1, a dilated IVC and any combination of mildly abnormal flow patterns (but no severe features) indicates mild congestion. In Grade 2, a dilated IVC and one severely abnormal flow pattern indicates moderate congestion. In Grade 3, a dilated IVC and two or more severely abnormal flow patterns indicates severe congestion.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: yahya m wahba, MD; Phone Number: 01211313554; Email: wahbayahya2007@mans.edu.eg
• Study Contact Backup: Name: ghada f amer, MD; Phone Number: 01008081333; Email: ghadafouad2018@gmail.com

Study Locations

• Egypt
  • Mansoura, Egypt
    • Recruiting
    • Nevert adel
    • Contact: Yahya M Wahba, MD; Phone Number: +201211313554; Email: yahyawahba@ymail.com
    • Contact: ghada F Amer, ass. prof.; Phone Number: 01008081333; Email: ghadafouad2018@gmail.com
    • Sub-Investigator: ghada F Amer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The aim of this study is to evaluate combination of inferior vena cava diameter, hepatic venous flow, and portal vein pulsatility index: venous excess ultrasound score (VEXUS Score) in predicting acute kidney injury in patients with sepsis.

Description

Inclusion Criteria:

• All patients with sepsis.
• Patients aged between 21 and 65.
• Both sexes

Exclusion Criteria:

• Patients refused to participate in the study.
• Renal failure.
• Right ventricular dysfunction and dilatation.
• Moderate to severe tricuspid regurge.
• Cases of cirrhosis with liver cell failure.
• Inadequate window.
• IVC thrombus

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between serial VEXUS score and AKI in patients with sepsis.	Correlation between serial VEXUS score and AKI in patients with sepsis.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess correlation between VEXUS score and hemodynamics: mean arterial pressure, central venous pressure, vasopressor use, urine output and daily fluid balance and serum lactate.	Assess correlation between VEXUS score and hemodynamics: mean arterial pressure, central venous pressure, vasopressor use, urine output and daily fluid balance and serum lactate.	4 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 30, 2024

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Estimated): December 20, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury
• Other Study ID Numbers: MS.22.10.2155

Drug and device information, study documents

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