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

Intensive Care Unit Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06176807
• Other study ID #: MS.22.10.2155
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: December 2023
• Source: Mansoura University
• Contact: yahya m wahba, MD
• Phone: 01211313554
• Email: wahbayahya2007[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 30, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Intensive Care Unit

Intervention

Radiation:
• Venous Excess Ultrasound Score
-- The IVC diameter : Grade 0: <5 mm with respiratory variation Grade I: 5-9 mm with respiratory variation Grade II: 10-19 mm with respiratory variation Grade III: >20 mm with respiratory variation Grade IV: >20 mm with minimal or no respiratory variation - Hepatic vein (HV) interrogation by pulsed wave Doppler identification and analysis of A, S, and D waves. Grade 0: normal S > D Grade I: S < D with antegrade S Grade III: S flat or inverted or biphasic trace - Portal vein Doppler (PD)as follow: Grade 0: <0.3 pulsatility index Grade I: 0.3-0.49 pulsatility index Grade III: 0.5-1.0 pulsatility index Pulsatility index is calculated as (Vmax - Vmin)/Vmax - VEXUS staging of venous congestion. (VEXUS ) Grade 0: IVC grade <III, HD grade 0, PV grade 0 Grade I: IVC grade IV, but normal HV/PV pattern Grade II: IVC grade IV with mild flow pattern abnormalities in HV/PV Grade III: IVC grade IV with severe flow pattern abnormalities in HV/PV

Locations

Country	Name	City	State
Egypt	Nevert adel	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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