NCT07040696

Brief Summary

To evaluate diagnostic accuracy of venous excess ultrasound score to predict acute kidney injury

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

June 22, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 18, 2025

Last Update Submit

June 28, 2025

Conditions

Keywords

preeclampsiaVEXUS scoreAKI

Outcome Measures

Primary Outcomes (1)

  • The accuracy of VEXUS score at admission to predict acute kidney injury

    within 48 hours of admission

Secondary Outcomes (3)

  • need for renal replacement therapy

    at 28 days of admission

  • Cumulative fluid balance

    within 48 hours of admission

  • In hospital mortality

    At 28 days of admission

Study Arms (1)

Preeclampsia with severe features

Features of severity will be defined according to American college of obstetric and gynacology guidelines

Device: Venous excess ultrasound score (VEXUS)

Interventions

Doppler examination of inferior vena cave, portal vein, hepatic vein, and intrarenal vein will be conducted by an experienced operator

Preeclampsia with severe features

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPreeclampsia with severe features is defined according to the American College of Obstetricians and Gynecologists (ACOG)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

preeclampsia with severe features

You may qualify if:

  • preeclampsia with severe features

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 6890, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 37154067BACKGROUND
  • Rola 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.

    PMID: 34146184BACKGROUND
  • Naqvi 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.

    PMID: 36694779BACKGROUND
  • Hassan 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.

    PMID: 36324072BACKGROUND

MeSH Terms

Conditions

Pre-EclampsiaAcute Kidney Injury

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia

Study Record Dates

First Submitted

June 18, 2025

First Posted

June 27, 2025

Study Start

June 22, 2025

Primary Completion

December 30, 2025

Study Completion

December 31, 2025

Last Updated

July 2, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) may not be shared due to privacy regulations, ethical considerations

Locations