Intensive Care UnitNCT06176807
Prediction of Acute Kidney Injury in Patients With Sepsis Using Venous Excess Ultrasound Score
An observational study of Intensive Care Unit, run by Mansoura University at 1 site in Egypt.
Trial summary
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis and septic shock are major healthcare problems, killing between one in three and one in six of those they affect. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intensive Care Unit
- What is being tested?
- Venous Excess Ultrasound Score
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 30 Jan 2024
- How long will I take part?
- 4 Months
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The aim of this study is to evaluate combination of inferior vena cava diameter, hepatic venous flow, and portal vein pulsatility index: venous excess ultrasound score (VEXUS Score) in predicting acute kidney injury in patients with sepsis.
Who may be able to join
- All patients with sepsis.
- Patients aged between 21 and 65.
- Both sexes
Who cannot join
- Patients refused to participate in the study.
- Renal failure.
- Right ventricular dysfunction and dilatation.
- Moderate to severe tricuspid regurge.
- Cases of cirrhosis with liver cell failure.
- Inadequate window.
- IVC thrombus
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Nevert adel
Al Mansurah
Yahya M Wahba, MD, +201211313554, yahyawahba@ymail.com
ghada F Amer, ass. prof., 01008081333, ghadafouad2018@gmail.com
About this study
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis and septic shock are major healthcare problems, killing between one in three and one in six of those they affect. organ dysfunction can be represented by the Sequential Organ Failure Assessment (SOFA) score of 2 points or more (respiratory rate of 22/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or less), which is associated with an in- hospital mortality greater than 10%.
Septic shock is defined as a subset of sepsis in which profound circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone. Patients with septic shock can be clinically identified by a vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (>18 mg/dL) in the absence of hypovolemia. This combination is associated with hospital mortality rates greater than 40%.
Read the detailed description
All patients with two out of four of Systemic Inflammatory Response Syndrome (SIRS) criteria (heart rate greater than 90, respiratory rate greater than 20, temperature greater or equal to 38 ⁰ C or less than 36⁰ C, altered mental state) and suspected infection and one of the following risk factors ( Age greater than 65 years, Recent surgery Immunocompromised AIDS, chemotherapy, neutropenia, diabetes, renal failure, hepatic failure, cancer, alcoholism)should be considered at risk of sepsis according to emergency department sepsis guidelines 2022.
The VExUS score ranges from Grades 0-3. In Grade 0, a non- dilated IVC (< 2 cm) indicates that no congestion is present. In Grades 1- 3, the IVC diameter is > 2 cm. In Grade 1, a dilated IVC and any combination of mildly abnormal flow patterns (but no severe features) indicates mild congestion. In Grade 2, a dilated IVC and one severely abnormal flow pattern indicates moderate congestion. In Grade 3, a dilated IVC and two or more severely abnormal flow patterns indicates severe congestion.
- Conditions
- Intensive Care Unit
- Being tested
- Venous Excess Ultrasound Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous Excess Ultrasound ScoreRadiation
-- The IVC diameter : Grade 0: <5 mm with respiratory variation Grade I: 5-9 mm with respiratory variation Grade II: 10-19 mm with respiratory variation Grade III: >20 mm with respiratory variation Grade IV: >20 mm with minimal or no respiratory variation
- Hepatic vein (HV) interrogation by pulsed wave Doppler identification and analysis of A, S, and D waves.
Grade 0: normal S > D Grade I: S < D with antegrade S Grade III: S flat or inverted or biphasic trace - Portal vein Doppler (PD)as follow: Grade 0: <0.3 pulsatility index Grade I: 0.3-0.49 pulsatility index Grade III: 0.5-1.0 pulsatility index Pulsatility index is calculated as (Vmax - Vmin)/Vmax
- VEXUS staging of venous congestion. (VEXUS ) Grade 0: IVC grade <III, HD grade 0, PV grade 0 Grade I: IVC grade IV, but normal HV/PV pattern Grade II: IVC grade IV with mild flow pattern abnormalities in HV/PV Grade III: IVC grade IV with severe flow pattern abnormalities in HV/PV
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between serial VEXUS score and AKI in patients with sepsis.
Correlation between serial VEXUS score and AKI in patients with sepsis.
Measured: 4 months
Secondary outcomes (1)
Assess correlation between VEXUS score and hemodynamics: mean arterial pressure, central venous pressure, vasopressor use, urine output and daily fluid balance and serum lactate.
Assess correlation between VEXUS score and hemodynamics: mean arterial pressure, central venous pressure, vasopressor use, urine output and daily fluid balance and serum lactate.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Sep 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion30 Jan 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 Mansoura 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
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevert Adel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176807
- Sponsor's protocol ID
- MS.22.10.2155
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Acute Kidney Injury in Patients With Sepsis Using Venous Excess Ultrasound Score
- ClinicalTrials.gov ID
- NCT06176807
- Acronym / sponsor ID
- MS.22.10.2155
- Conditions
- Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 20 Dec 2023 (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.
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis and septic shock are major healthcare problems, killing between one in three and one in six of those they affect. organ dysfunction can be represented by the Sequential Organ Failure Assessment (SOFA) score of 2 points or more (respiratory rate of 22/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or less), which is associated with an in- hospital mortality greater than 10%.
Septic shock is defined as a subset of sepsis in which profound circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone. Patients with septic shock can be clinically identified by a vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (>18 mg/dL) in the absence of hypovolemia. This combination is associated with hospital mortality rates greater than 40%.
Detailed description
All patients with two out of four of Systemic Inflammatory Response Syndrome (SIRS) criteria (heart rate greater than 90, respiratory rate greater than 20, temperature greater or equal to 38 ⁰ C or less than 36⁰ C, altered mental state) and suspected infection and one of the following risk factors ( Age greater than 65 years, Recent surgery Immunocompromised AIDS, chemotherapy, neutropenia, diabetes, renal failure, hepatic failure, cancer, alcoholism)should be considered at risk of sepsis according to emergency department sepsis guidelines 2022.
The VExUS score ranges from Grades 0-3. In Grade 0, a non- dilated IVC (< 2 cm) indicates that no congestion is present. In Grades 1- 3, the IVC diameter is > 2 cm. In Grade 1, a dilated IVC and any combination of mildly abnormal flow patterns (but no severe features) indicates mild congestion. In Grade 2, a dilated IVC and one severely abnormal flow pattern indicates moderate congestion. In Grade 3, a dilated IVC and two or more severely abnormal flow patterns indicates severe congestion.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 4 Months
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The aim of this study is to evaluate combination of inferior vena cava diameter, hepatic venous flow, and portal vein pulsatility index: venous excess ultrasound score (VEXUS Score) in predicting acute kidney injury in patients with sepsis.
Key inclusion criteria (3 listed)
- All patients with sepsis.
- Patients aged between 21 and 65.
- Both sexes
Key exclusion criteria (7 listed)
- Patients refused to participate in the study.
- Renal failure.
- Right ventricular dysfunction and dilatation.
- Moderate to severe tricuspid regurge.
- Cases of cirrhosis with liver cell failure.
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 |
|---|---|---|
| Venous Excess Ultrasound Score-- The IVC diameter : Grade 0: <5 mm with respiratory variation Grade I: 5-9 mm with respiratory variation Grade II: 10-19 mm with respiratory variation Grade III: >20 mm with respiratory variation Grade IV: >20 mm with minimal or no respiratory variation - Hepatic vein (HV) interrogation by pulsed wave Doppler identification and analysis of A, S, and D waves. Grade 0: normal S > D Grade I: S < D with antegrade S Grade III: S flat or inverted or biphasic trace - Portal vein Doppler (PD)as follow: Grade 0: <0.3 pulsatility index Grade I: 0.3-0.49 pulsatility index Grade III: 0.5-1.0 pulsatility index Pulsatility index is calculated as (Vmax - Vmin)/Vmax - VEXUS staging of venous congestion. (VEXUS ) Grade 0: IVC grade <III, HD grade 0, PV grade 0 Grade I: IVC grade IV, but normal HV/PV pattern Grade II: IVC grade IV with mild flow pattern abnormalities in HV/PV Grade III: IVC grade IV with severe flow pattern abnormalities in HV/PV | Radiation | – |
Primary outcome
Correlation between serial VEXUS score and AKI in patients with sepsis.
Time frame: 4 months
Correlation between serial VEXUS score and AKI in patients with sepsis.
1 secondary outcome
Assess correlation between VEXUS score and hemodynamics: mean arterial pressure, central venous pressure, vasopressor use, urine output and daily fluid balance and serum lactate.
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit, run by Mansoura University at 1 site in Egypt.
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 3 inclusion and 7 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 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 yahya m wahba, MD (01211313554, wahbayahya2007@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between serial VEXUS score and AKI in patients with sepsis. (time frame: 4 months). 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 20 Dec 2023.