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

Recruiting

• Conditions: Intensive Care Unit

• Registration Number: NCT06176807
• Lead Sponsor: Mansoura University

Brief Summary

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%.

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 Timeline

• Study Start: 2023-09-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-11
• Last Update Submitted: 2023-12-11
• Study First Posted: 2023-12-20
• Last Update Posted: 2023-12-20
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between serial VEXUS score and AKI in patients with sepsis.	4 months	Correlation between serial VEXUS score and AKI in patients with sepsis.

Secondary Outcome Measures

Name	Time	Method
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	Assess correlation between VEXUS score and hemodynamics: mean arterial pressure, central venous pressure, vasopressor use, urine output and daily fluid balance and serum lactate.

Trial Locations

Locations (1)

Nevert adel; 🇪🇬 Mansoura, Egypt