PreeclampsiaNCT07040696
Accuracy of Venous Excess Ultrasound Score at Hospital Admission to Predict Acute Kidney Injury
An observational study of Preeclampsia and Acute Kidney Injury, run by Cairo University at 1 site in Egypt.
Trial summary
To evaluate diagnostic accuracy of venous excess ultrasound score to predict acute kidney injury Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Preeclampsia, Acute Kidney Injury
- What is being tested?
- Venous excess ultrasound score (VEXUS)
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jun 2025to 27 May 2026
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: preeclampsia with severe features
Who may be able to join
- preeclampsia with severe features
Who cannot join
- Patient refusal
- Preexisting renal impairment (defined as baseline serum creatinine > 1.3 mg/dl)
- Inability to obtain adequate Doppler views
- Renal transplantation
- Previous need for renal replacement therapy
- Known peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of the Venous Excess Ultrasound Score at Hospital Admission to Predict Acute Kidney Injury in Preeclampsia With Severe Features: A Prospective Observational Study
To evaluate diagnostic accuracy of venous excess ultrasound score to predict acute kidney injury
Read the detailed description
Preeclampsia is a common health problem during pregnancy. such condition may result in serious consequences including acute kidney injury. researchers of this study aim to evaluate the ability of venous excess ultrasound score at hospital admission to predict acute kidney injury in preeclampsia with severe features
- Conditions
- Preeclampsia, Acute Kidney Injury
- Being tested
- Venous excess ultrasound score (VEXUS)
- Keywords
- preeclampsia, VEXUS score, AKI
- Medical subject headings
- Pre-Eclampsia, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous excess ultrasound score (VEXUS)Device
Doppler examination of inferior vena cave, portal vein, hepatic vein, and intrarenal vein will be conducted by an experienced operator
| Study group | Role | What they receive |
|---|---|---|
| Preeclampsia with severe features | Features of severity will be defined according to American college of obstetric and gynacology guidelines Receives: Device: Venous excess ultrasound score (VEXUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of VEXUS score at admission to predict acute kidney injury
Measured: within 48 hours of admission
Secondary outcomes (3)
need for renal replacement therapy
Measured: at 28 days of admission
Cumulative fluid balance
Measured: within 48 hours of admission
In hospital mortality
Measured: At 28 days of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start22 Jun 2025
- Primary completion27 May 2026
- Study completion27 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adolf Helmy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040696
- Sponsor's protocol ID
- VEXUS score in preeclampsia
- Status last verified
- May 2026
- First submitted
- 18 Jun 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) may not be shared due to privacy regulations, ethical considerations
Publications
Viana-Rojas JA, Argaiz E, Robles-Ledesma M, Arias-Mendoza A, Najera-Rojas NA, Alonso-Bringas AP, De Los Rios-Arce LF, Armenta-Rodriguez J, Gopar-Nieto R, Briseno-De la Cruz JL, Gonzalez-Pacheco H, Sierra-Lara Martinez D, Gonzalez-Salido J, Lopez-Gil S, Araiza-Garaygordobil D. Venous excess ultrasound score and acute kidney injury in patients with acute coronary syndrome. Eur Heart J Acute Cardiovasc Care. 2023 Jul 7;12(7):413-419. doi: 10.1093/ehjacc/zuad048.
PubMed 37154067Rola P, Miralles-Aguiar F, Argaiz E, Beaubien-Souligny W, Haycock K, Karimov T, Dinh VA, Spiegel R. Clinical applications of the venous excess ultrasound (VExUS) score: conceptual review and case series. Ultrasound J. 2021 Jun 19;13(1):32. doi: 10.1186/s13089-021-00232-8.
PubMed 34146184Naqvi R, Hossain N, Butt S, Bhellar Z, Fatima E, Imtiaz S, Moosa PG, Abbas K, Jafri SB, Khan S. Efficacy of multiple Biomarkers: NGAL, KIM1, Cystatin C and IL18 in predicting pregnancy related acute kidney injury. Pak J Med Sci. 2023 Jan-Feb;39(1):34-40. doi: 10.12669/pjms.39.1.6930.
PubMed 36694779Hassan M, Mayanja R, Ssalongo WGM, Robert N, Mark LH, Samson O, Muhindo R. Incidence and predictors of acute kidney injury among women with severe pre-eclampsia at Mbarara Regional Referral Hospital. BMC Nephrol. 2022 Nov 2;23(1):353. doi: 10.1186/s12882-022-02972-8.
PubMed 36324072
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of the Venous Excess Ultrasound Score at Hospital Admission to Predict Acute Kidney Injury in Preeclampsia With Severe Features: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07040696
- Acronym / sponsor ID
- VEXUS score in preeclampsia
- Conditions
- Preeclampsia, Acute Kidney Injury
- Keywords
- preeclampsia, VEXUS score, AKI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Jun 2025 (actual)
- Primary completion
- 27 May 2026 (actual)
- Study completion
- 27 May 2026 (actual)
- First posted
- 27 Jun 2025 (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.
To evaluate diagnostic accuracy of venous excess ultrasound score to predict acute kidney injury
Detailed description
Preeclampsia is a common health problem during pregnancy. such condition may result in serious consequences including acute kidney injury. researchers of this study aim to evaluate the ability of venous excess ultrasound score at hospital admission to predict acute kidney injury in preeclampsia with severe features
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preeclampsia with severe features | – | Device: Venous excess ultrasound score (VEXUS)Features of severity will be defined according to American college of obstetric and gynacology guidelines |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- preeclampsia with severe features
Key inclusion criteria (1 listed)
- preeclampsia with severe features
Key exclusion criteria (6 listed)
- Patient refusal
- Preexisting renal impairment (defined as baseline serum creatinine > 1.3 mg/dl)
- Inability to obtain adequate Doppler views
- Renal transplantation
- Previous need for renal replacement therapy
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 (VEXUS)Doppler examination of inferior vena cave, portal vein, hepatic vein, and intrarenal vein will be conducted by an experienced operator | Device | Preeclampsia with severe features |
Primary outcome
The accuracy of VEXUS score at admission to predict acute kidney injury
Time frame: within 48 hours of admission
3 secondary outcomes
need for renal replacement therapy
Time frame: at 28 days of admission
Cumulative fluid balance
Time frame: within 48 hours of admission
In hospital mortality
Time frame: At 28 days of admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Results publication: PubMed 37154067Viana-Rojas JA, Argaiz E, Robles-Ledesma M, Arias-Mendoza A, Najera-Rojas NA, Alonso-Bringas AP, De Los Rios-Arce LF, Armenta-Rodriguez J, Gopar-Nieto R, Briseno-De la Cruz JL, Gonzalez-Pacheco H, Sierra-Lara Martinez D, Gonzalez-Salido J, Lopez-Gil S, Araiza-Garaygordobil D. Venous excess ultrasound score and acute kidney injury in patients with acute coronary syndrome. Eur Heart J Acute Cardiovasc Care. 2023 Jul 7;12(7):413-419. doi: 10.1093/ehjacc/zuad048.
- Results publication: PubMed 34146184Rola P, Miralles-Aguiar F, Argaiz E, Beaubien-Souligny W, Haycock K, Karimov T, Dinh VA, Spiegel R. Clinical applications of the venous excess ultrasound (VExUS) score: conceptual review and case series. Ultrasound J. 2021 Jun 19;13(1):32. doi: 10.1186/s13089-021-00232-8.
- Results publication: PubMed 36694779Naqvi R, Hossain N, Butt S, Bhellar Z, Fatima E, Imtiaz S, Moosa PG, Abbas K, Jafri SB, Khan S. Efficacy of multiple Biomarkers: NGAL, KIM1, Cystatin C and IL18 in predicting pregnancy related acute kidney injury. Pak J Med Sci. 2023 Jan-Feb;39(1):34-40. doi: 10.12669/pjms.39.1.6930.
- Results publication: PubMed 36324072Hassan M, Mayanja R, Ssalongo WGM, Robert N, Mark LH, Samson O, Muhindo R. Incidence and predictors of acute kidney injury among women with severe pre-eclampsia at Mbarara Regional Referral Hospital. BMC Nephrol. 2022 Nov 2;23(1):353. doi: 10.1186/s12882-022-02972-8.
- Individual participant dataSharing planned: No. Individual participant data (IPD) may not be shared due to privacy regulations, ethical considerations
Related trials for Preeclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Preeclampsia and Acute Kidney Injury, run by Cairo 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 29 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of VEXUS score at admission to predict acute kidney injury (time frame: within 48 hours of admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07040696, which also lists 4 linked publications.
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 29 May 2026.