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

NCT06176807 | Unknown

• 1 other identifier: MS.22.10.2155
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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%.

Conditions

Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

Venous Excess Ultrasound Score RADIATION

\-- 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

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Nevert adel

Al Mansurah, Egypt

RECRUITING

Central Study Contacts

yahya m wahba, MD

CONTACT

01211313554; wahbayahya2007@mans.edu.eg

ghada f amer, MD

CONTACT

01008081333; ghadafouad2018@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: September 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 30, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

EG (1)