Clinical trial NCT06305403: VEXUS and NGAL in the Diagnosis and Prognosis of Sepsis-associated Acute Kidney Injury
Official title: Comparison of Venous Excess Ultrasound Score (VExUS) With Neutrophil Gelatinase-associated Lipocalin (NGAL) in the Diagnosis and Prognosis of Sepsis-associated Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sepsis
Acute Kidney Injury
Keywords: ngal
vexus
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: sepsis and septic shock in ICU

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.

Detailed description: 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.

Poor abdominal echogenicity, age \< 18 years, other conditions causing shock (hypovolemic, cardiogenic, neurogenic), life expectancy less than 24 hours, pregnancy, vasospastic disease, intraperitoneal pressure \> 15 mm Hg, obstructive renal failure or suspected renal artery Defined as the presence of stenosis, 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 (GFR) \< 30 ml/min/1.73m2. Those with severe acute or chronic renal failure will be excluded from the study.

After patients are diagnosed with sepsis/septic shock, in accordance with the Surviving Sepsis 2021 guide; Cultures will be sent and antibiotics, fluids, and vasopressor treatment will be started if necessary. Standard monitoring of the patients (heart rate, mean arterial pressure, peripheral oxygen saturation) will be performed.

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 ACI will be made according to KDIGO.

According to KDIGO, patients will be divided into two groups: those who develop ACI and those who do not.

By comparing plasma NGAL and VEXUS scores between groups, the sensitivity and specificity of the VEXUS score in determining ACI will be determined.

Blood samples for plasma NGAL level will be taken within the first 24 hours of sepsis diagnosis, after the patient has received one-hour bundle therapy and the patient has been stabilized. The VEXUS score will be measured simultaneously with ultrasound. Both parameters will be repeated after the 72nd hour.

VEXUS score measurement will be performed by an experienced practitioner with a transparietal 2-5 MHz curvi-linear probe (Ch5-2 ultrasound transducer, Siemens Healthineers ACUSON NX3) and the values and graphs will be saved to external memory.

For plasma NGAL level, approximately 10 ml of blood samples taken from the peripheral vein will be centrifuged at 1500 rpm for 5 minutes and stored at -80 °C.

Patients' age, gender, weight, height, body mass index, accompanying diseases (e.g., diabetes mellitus, hypertension, heart failure, COPD, cancer, anemia, poisonings, trauma), source and type of infection, procalcitonin, c-reactive protein (CRP), lactate, routine markers of circulation, central venous pressure, medications (diuretic, vasopressor, inotropic agent, antimicrobial, insulin, colloid, albumin use, blood and blood product transfusion), recent use of contrast material, fluid balance, renal replacement. The need for treatment, the need for mechanical ventilation treatment, the stage of the AKI group according to KDIGO, Acute Physiology and Chronic Health Evaluation (APACHE II) score, Sequential Organ Failure Assesment (SOFA) score, hospital stay and 28-day mortality will be recorded.

Eligibility criteria: Inclusion Criteria:

* sepsis septic shock

Exclusion Criteria:

* 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

Primary outcomes:
measure: ngal
timeFrame: first and fifth days
measure: VEXUS
timeFrame: first and fifth days
Secondary outcomes:
measure: MORTALİTY
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
References: