NCT05368766

Brief Summary

To assess predictive value of venous excess ultrasound score in cardiorenal patient management

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Status
unknown

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

April 13, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

April 13, 2022

Last Update Submit

May 6, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • response to diuretic

    Response to diuretic therapy in cardiorenal patients (failure to produce 0.5 ml/kg/h of urine after administration of at least double the dose of the patient's home diuretic therapy or after administration of 250 mg of Lasix and 10 mg of Metolazone in diuretic naïve patientfailure to produce 0.5 ml/kg/h of urine after administration of at least double the dose of the patient's home diuretic therapy or after administration of 250 mg of Lasix and 10 mg of Metolazone in diuretic naïve patient)

    Baseline

Secondary Outcomes (3)

  • Length of ICU stay

    Through study completion, an average of 2 weeks

  • Worsening renal function

    Through study completion, an average of 2 weeks

  • Need to ultrafiltration

    Baseline

Interventions

The venous excess ultrasound (VExUS) score incorporates hepatic venous, intrarenal venous Doppler, inferior vena cava (IVC) assessment, and portal vein Doppler

Response to diuretic therapy

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cardiorenal patients above 18 years old

You may qualify if:

  • Patients with congestive heart failure and GFR less than 100 ml/minute

You may not qualify if:

  • Patients below 18 years old. Patients with liver cirrhosis and portal hypertension. Patients with IVC thrombus. Patients with inadequate ultrasonography window.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Rangaswami J, Bhalla V, Blair JEA, Chang TI, Costa S, Lentine KL, Lerma EV, Mezue K, Molitch M, Mullens W, Ronco C, Tang WHW, McCullough PA; American Heart Association Council on the Kidney in Cardiovascular Disease and Council on Clinical Cardiology. Cardiorenal Syndrome: Classification, Pathophysiology, Diagnosis, and Treatment Strategies: A Scientific Statement From the American Heart Association. Circulation. 2019 Apr 16;139(16):e840-e878. doi: 10.1161/CIR.0000000000000664.

    PMID: 30852913BACKGROUND
  • Zhang L, Chen Z, Diao Y, Yang Y, Fu P. Associations of fluid overload with mortality and kidney recovery in patients with acute kidney injury: A systematic review and meta-analysis. J Crit Care. 2015 Aug;30(4):860.e7-13. doi: 10.1016/j.jcrc.2015.03.025. Epub 2015 Apr 9.

    PMID: 25979272BACKGROUND
  • 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
  • Bhardwaj V, Vikneswaran G, Rola P, Raju S, Bhat RS, Jayakumar A, Alva A. 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 Cardiorenal Syndrome: A Prospective Cohort Study. Indian J Crit Care Med. 2020 Sep;24(9):783-789. doi: 10.5005/jp-journals-10071-23570.

    PMID: 33132560BACKGROUND
  • Shimada S, Hirose T, Takahashi C, Sato E, Kinugasa S, Ohsaki Y, Kisu K, Sato H, Ito S, Mori T. Pathophysiological and molecular mechanisms involved in renal congestion in a novel rat model. Sci Rep. 2018 Nov 14;8(1):16808. doi: 10.1038/s41598-018-35162-4.

    PMID: 30429498BACKGROUND
  • Neal CR, Arkill KP, Bell JS, Betteridge KB, Bates DO, Winlove CP, Salmon AHJ, Harper SJ. Novel hemodynamic structures in the human glomerulus. Am J Physiol Renal Physiol. 2018 Nov 1;315(5):F1370-F1384. doi: 10.1152/ajprenal.00566.2017. Epub 2018 Jun 20.

    PMID: 29923763BACKGROUND

MeSH Terms

Conditions

Cardio-Renal Syndrome

Interventions

Diuretics

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHeart FailureHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Abdallah I. Kelany, MD

    university

    STUDY DIRECTOR

Central Study Contacts

Hany A. Habib, Master

CONTACT

Ahmad B. Abdelrehim, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 13, 2022

First Posted

May 10, 2022

Study Start

June 1, 2022

Primary Completion

June 1, 2024

Study Completion

August 1, 2024

Last Updated

May 10, 2022

Record last verified: 2022-05