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

Not yet recruiting
Conditions
Acute Kidney Injury
Sepsis
Interventions
Diagnostic Test: serum creatinin level
Registration Number
NCT06305403
Lead Sponsor
Inonu University
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
100
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
2serum creatinin levelPatients with sepsis who not develop AKI
1serum creatinin levelPatients with sepsis who develop AKI
Primary Outcome Measures
NameTimeMethod
ngalfirst and fifth days

neutrophil gelatinase-associated lipocalin

VEXUSfirst and fifth days

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.

Secondary Outcome Measures
NameTimeMethod
MORTALİTY28 days

28 days mortality

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