Intensive Care UnitNCT06331234
Effects of Vena Cava Inferior Measurements on AKI and Mortality.
An observational study of Intensive Care Unit and Acute Kidney Injury, run by Inonu University.
Trial summary
Fluid overload is harmful in critically ill patients; In addition to increasing mortality, it may increase the incidence of acute kidney injury (AKI), length of ICU stay, and duration of mechanical ventilation by causing end-organ damage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit, Acute Kidney Injury
- What is being tested?
- Vena cava inferior diameter
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to intensive care
Who may be able to join
- Patients with a life expectancy of more than 24 hours >18 age
Who cannot join
- Poor abdominal echogenicity age < 18 postoperative patients, intoxications, life expectancy is less than 24 hours, pregnancy, intraperitoneal pressure > 15 mm Hg, obstructive renal failure or suspected, presence of renal artery stenosis, patients who have had liver and kidney transplants, Presence of liver and kidney tumors, patients receiving dialysis treatment, single kidney and other kidney abnormalities, presence of acute mesenteric ischemia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Determination of the Effects of Vena Cava Inferior Measurements on Acute Kidney Injury and Mortality During Intensive Care Admission.
Fluid overload is harmful in critically ill patients; In addition to increasing mortality, it may increase the incidence of acute kidney injury (AKI), length of ICU stay, and duration of mechanical ventilation by causing end-organ damage. (1-3) Mortality attributable to AKI is 20% and is an independent determinant of mortality. (4) Venous load ultrasonography score (VExUS) is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler (PW-Doppler) morphology of the hepatic, portal and renal veins. It has been proposed as a score to assess systemic congestion. When the IVC diameter is < 2 cm, it means there is no congestion and VEXUS is 0. Mild congestion: In addition to the IVC measuring approximately 2 cm, normal patterns such as the systolic wave being greater than the diastolic wave in the hepatic vein PW-doppler, pulsatility below 30% in the portal vein Doppler, continuous flow in the renal vein PW-doppler, or slightly abnormal patterns, i.e. hepatic The systolic wave in vein PW-doppler is smaller than the diastolic wave, the pulsatility in portal PW-doppler is between 30-50%, and the renal vein PW-doppler is accompanied by biphasic flow, and VEXUS is scored as 1. Moderate congestion is scored as VEXUS 2, which is measured as IVC 2 cm or more, plus inversion of the systolic wave on hepatic vein PW-doppler, pulsatility greater than 50% on portal PW-doppler, and discontinuous monophasic flow with only the diastolic phase on renal vein PW-doppler. It is accompanied by one of the serious abnormal patterns such as There is severe congestion, that is, VEXUS 3: IVC diameter of 2 cm or more and the presence of at least two seriously abnormal PW-Doppler morphologies. (5) The primary aim of this study is to describe the prevalence of venous congestion based on VExUS in general ICU patients. Secondary outcomes were to evaluate the association between VExUS, AKI, and 28-day mortality.
Read the detailed description
In the first 24 hours of hospitalization, the inferior vena cava will be evaluated by an experienced clinician (INTENSIVE CARE SPECIALIST). If the IVC diameter is below 2 cm, the collapsibility index will be checked if the patient is not receiving mechanical ventilation (MV) treatment, and the distensibility index will be checked if the patient is receiving MV treatment. If the IVC diameter is over 2 cm, VEXUS will be performed. As primary outcomes, the development of acute kidney injury within one week and 28-day mortality will be recorded. Acute kidney injury will be performed according to KDIGO criteria. Patients' age, gender, body mass index, comorbidities, medications used before admission to intensive care (especially ACE inhibitors and ARBs), reason for admission to intensive care, fluid therapy applied in the first 24 hours, and fluid balance in the first 24 hours will be recorded. In patients taken from the emergency department, the amount of fluid taken and removed in the emergency room will also be recorded. Additionally, the use of vasopressors/vasodilators, inotropes, diuretics, colloids and blood products will be recorded. The central venous pressure of patients with a central venous catheter will also be recorded on the first day.
Patients will undergo transthoracic echocardiography and lung ultrasonography simultaneously, and ejection fraction and TAPSE will be evaluated.
- Conditions
- Intensive Care Unit, Acute Kidney Injury
- Being tested
- Vena cava inferior diameter
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vena cava inferior diameterOther
Also called VEXUS score
he VExUS score is obtained as follows: VEXUS 0: IVC < 20mm; VEXUS 1: IVC ≥ 20mm with normal patterns or mild abnormalities; VEXUS 2: IVC ≥ 20mm with severe abnormality in at least one pattern and VEXUS 3: IVC ≥ 20mm and severe abnormalities in multiple patterns.
What is being measured
The primary outcome is the main question the study is designed to answer.
acute kidney injury
Measured: 7 days
mortality
in 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.
- First posted26 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Belin Ozer, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331234
- Sponsor's protocol ID
- VCI
- Status last verified
- Apr 2024
- First submitted
- 20 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effects of Vena Cava Inferior Measurements on Acute Kidney Injury and Mortality During Intensive Care Admission.
- ClinicalTrials.gov ID
- NCT06331234
- Acronym / sponsor ID
- VCI
- Conditions
- Intensive Care Unit, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fluid overload is harmful in critically ill patients; In addition to increasing mortality, it may increase the incidence of acute kidney injury (AKI), length of ICU stay, and duration of mechanical ventilation by causing end-organ damage. (1-3) Mortality attributable to AKI is 20% and is an independent determinant of mortality. (4) Venous load ultrasonography score (VExUS) is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler (PW-Doppler) morphology of the hepatic, portal and renal veins. It has been proposed as a score to assess systemic congestion. When the IVC diameter is < 2 cm, it means there is no congestion and VEXUS is 0. Mild congestion: In addition to the IVC measuring approximately 2 cm, normal patterns such as the systolic wave being greater than the diastolic wave in the hepatic vein PW-doppler, pulsatility below 30% in the portal vein Doppler, continuous flow in the renal vein PW-doppler, or slightly abnormal patterns, i.e. hepatic The systolic wave in vein PW-doppler is smaller than the diastolic wave, the pulsatility in portal PW-doppler is between 30-50%, and the renal vein PW-doppler is accompanied by biphasic flow, and VEXUS is scored as 1. Moderate congestion is scored as VEXUS 2, which is measured as IVC 2 cm or more, plus inversion of the systolic wave on hepatic vein PW-doppler, pulsatility greater than 50% on portal PW-doppler, and discontinuous monophasic flow with only the diastolic phase on renal vein PW-doppler. It is accompanied by one of the serious abnormal patterns such as There is severe congestion, that is, VEXUS 3: IVC diameter of 2 cm or more and the presence of at least two seriously abnormal PW-Doppler morphologies. (5) The primary aim of this study is to describe the prevalence of venous congestion based on VExUS in general ICU patients. Secondary outcomes were to evaluate the association between VExUS, AKI, and 28-day mortality.
Detailed description
In the first 24 hours of hospitalization, the inferior vena cava will be evaluated by an experienced clinician (INTENSIVE CARE SPECIALIST). If the IVC diameter is below 2 cm, the collapsibility index will be checked if the patient is not receiving mechanical ventilation (MV) treatment, and the distensibility index will be checked if the patient is receiving MV treatment. If the IVC diameter is over 2 cm, VEXUS will be performed. As primary outcomes, the development of acute kidney injury within one week and 28-day mortality will be recorded. Acute kidney injury will be performed according to KDIGO criteria. Patients' age, gender, body mass index, comorbidities, medications used before admission to intensive care (especially ACE inhibitors and ARBs), reason for admission to intensive care, fluid therapy applied in the first 24 hours, and fluid balance in the first 24 hours will be recorded. In patients taken from the emergency department, the amount of fluid taken and removed in the emergency room will also be recorded. Additionally, the use of vasopressors/vasodilators, inotropes, diuretics, colloids and blood products will be recorded. The central venous pressure of patients with a central venous catheter will also be recorded on the first day.
Patients will undergo transthoracic echocardiography and lung ultrasonography simultaneously, and ejection fraction and TAPSE will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to intensive care
Key inclusion criteria (1 listed)
- Patients with a life expectancy of more than 24 hours >18 age
Key exclusion criteria (1 listed)
- Poor abdominal echogenicity age < 18 postoperative patients, intoxications, life expectancy is less than 24 hours, pregnancy, intraperitoneal pressure > 15 mm Hg, obstructive renal failure or suspected, presence of renal artery stenosis, patients who have had liver and kidney transplants, Presence of liver and kidney tumors, patients receiving dialysis treatment, single kidney and other kidney abnormalities, presence of acute mesenteric ischemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vena cava inferior diameterAlso: VEXUS scorehe VExUS score is obtained as follows: VEXUS 0: IVC < 20mm; VEXUS 1: IVC ≥ 20mm with normal patterns or mild abnormalities; VEXUS 2: IVC ≥ 20mm with severe abnormality in at least one pattern and VEXUS 3: IVC ≥ 20mm and severe abnormalities in multiple patterns. | Other | – |
Primary outcome
acute kidney injury
Time frame: 7 days
mortality
Time frame: 28 days
in 28 days mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit 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 1 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 (+904223410660, abelinozer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute kidney injury (time frame: 7 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.