Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06305403 |
| Other study ID # |
VEXUS1 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2024 |
| Est. completion date |
May 18, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Inonu University |
| Contact |
Ayse B OZER |
| Phone |
90-4223410660 |
| Email |
abelinozer[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
