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SepsisNCT06305403

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

An observational study of Sepsis and Acute Kidney Injury, run by Inonu University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Sepsis, Acute Kidney Injury
What is being tested?
serum creatinin level
How many people
100 participants
Where
No sites listed yet
Study dates
1 May 2024to 18 May 2025
How long will I take part?
5 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Adult, Older adult

Study population: sepsis and septic shock in ICU

Who may be able to join

  • sepsis septic shock

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

About this study

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

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.

Read more

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.

Read the 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.

Being tested
serum creatinin level
Keywords
ngal, vexus
Medical subject headings
Sepsis, Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • serum creatinin levelDiagnostic test

    Also called urine output

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

Study groups in NCT06305403
Study groupRoleWhat they receive
1Patients with sepsis who develop AKI
Receives: Diagnostic Test: serum creatinin level
2Patients with sepsis who not develop AKI
Receives: Diagnostic Test: serum creatinin level

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ngal

    neutrophil gelatinase-associated lipocalin

    Measured: first and fifth days

  2. 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.

    Measured: first and fifth days

Secondary outcomes (1)
  1. MORTALİTY

    28 days mortality

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start1 May 2024 (estimated)
  3. Primary completion18 Mar 2025 (estimated)
  4. Study completion18 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
5 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06305403
Sponsor's protocol ID
VEXUS1
Status last verified
Apr 2024
First submitted
5 Mar 2024
Last updated
23 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis and Acute Kidney Injury, run by Inonu University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ayse B OZER (90-4223410660 ext. 3107, abelinozer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ngal (time frame: first and fifth days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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