VEXUS and NGAL in the Diagnosis and Prognosis of Sepsis-associated Acute Kidney Injury

NCT06305403 | Not Yet Recruiting

• 1 other identifier: VEXUS1
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this prospective observational study, patients hospitalized in mixed intensive care unit, aged between 18 and 80, and diagnosed with sepsis and septic shock according to sepsis-3 criteria will be included. To determine whether patients develop AKI during the first five days of ICU admission, creatinine and urine output will be monitored daily for the first five days of ICU admission according to KDIGO criteria. Clinical diagnosis and treatment of AKI will be made according to KDIGO. According to KDIGO, patients will be divided into two groups: those who develop AKI and those who do not. By comparing plasma NGAL and VEXUS scores between groups, the sensitivity and specificity of the VEXUS score in determining AKI will be determined.

Conditions

Sepsis; Acute Kidney Injury

Keywords

ngal; vexus

Outcome Measures

Primary Outcomes (2)

• ngal

  neutrophil gelatinase-associated lipocalin

  first and fifth days

• VEXUS

  venous excess ultrasound score (If VCI diameter is \< 2 cm, there is no congestion. If the VExUS score is 0, and you do not need to proceed further. If VCI\>2, congestion is present. Further examination is necessary to determine the severity of congestion and VExUS scores 1-3.Each of the hepatic, portal and renal veins are subsequently examined and classified as normal, mildly congested, or severely congested. The VExUS system has four grades: Grade 0 represents no congestion in any organ, Grade 1 represents only mild congestive findings, Grade 2 represents severe congestive findings in only one organ, and Grade 3 represents severe congestive findings in at least two out of three organ systems.

  first and fifth days

Secondary Outcomes (1)

• MORTALİTY

  28 days

Study Arms (2)

1

Patients with sepsis who develop AKI

Diagnostic Test: serum creatinin level

2

Patients with sepsis who not develop AKI

Diagnostic Test: serum creatinin level

Interventions

serum creatinin level DIAGNOSTIC_TEST

Serum creatinine and urine amounts will be checked for five days.

Also known as: urine output

1; 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

sepsis and septic shock in ICU

You may qualify if:

• sepsis septic shock

You may not qualify if:

• Poor abdominal echogenicity,
• other conditions causing shock (hypovolemic, cardiogenic, neurogenic),
• life expectancy less than 24 hours, pregnancy, vasospastic disease, intraperitoneal pressure \> 15 mm Hg, obstructive renal failure liver and kidney transplanted patients, liver and kidney tumors, patients receiving dialysis treatment, single kidney and other kidney abnormalities, right heart failure, acute mesenteric ischemia chronic renal failure

Sponsors & Collaborators

• Inonu University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample for blood ngal level

MeSH Terms

Conditions

Sepsis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Ayse B OZER

CONTACT

90-4223410660; abelinozer@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Intensive Care Unit

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: May 1, 2024
• Primary Completion: March 18, 2025
• Study Completion: May 18, 2025
• Last Updated: April 23, 2024

Record last verified: 2024-04