Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305403
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-03-05
Brief Title:
VEXUS and NGAL in the Diagnosis and Prognosis of Sepsis-associated Acute Kidney Injury
Sponsor:
Inonu University
Organization:
Inonu University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 mlmin173m2 Those with severe acute or chronic renal failure will be excluded from the study
After patients are diagnosed with sepsisseptic 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 eg 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
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 mlmin173m2 Those with severe acute or chronic renal failure will be excluded from the study
After patients are diagnosed with sepsisseptic 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None