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Status unknownNCT05368766Updated May 10, 2022

Predictive Value of Venous Excess Ultrasound Score in Management of Cardiorenal Patients

An observational study in Cardio-Renal Syndrome, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-10.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
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Study summary

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

Read the detailed description

Cardiorenal syndrome encompasses a spectrum of disorders involving both the heart and kidneys in which acute or chronic dysfunction in 1 organ may induce acute or chronic dysfunction in the other organ.

Fluid overload is deleterious in critically ill patients; apart from increased mortality, it can cause end-organ damage, thereby increasing the incidence of acute kidney injury (AKI), length of stay in ICU, and duration of mechanical ventilation.

Elevation of central venous pressure is directly transmitted to the renal veins because venous vascular resistance is negligible. As the encapsulated kidney has little room to expand, venous congestion causes renal interstitial hydrostatic pressure to increase. Furthermore, as the post-glomerular vascular and tubular network is a low-pressure system , the increase in the renal interstitial pressure causes compression or even occlusion of renal tubules. That in turn results in reduction or even shut down of tubular flow and shut down in the glomerular filtration .

The venous excess ultrasound (VExUS) score incorporates hepatic venous, intrarenal venous Doppler, inferior vena cava (IVC) assessment, and portal vein Doppler. By utilizing multiple parameters, the negative aspects of individual parameters might get negated and could be considered as a reliable tool to assess congestion of kidneys.

The investigators hypothesise that VExUS score could be valuable in predicting cardiorenal patients who need ultrafiltration in ICU. In this study the investigators will use VEXSUS score to predict response to diuretic therapy, to evaluate patients' volume status, and to predict mortality in cardiorenal patient

Every patient will be subjected to

  1. Medical history taking.
  2. Complete physical examination.
  3. Routine laboratory investigations including baseline urea, creatinine, electrolytes, urine analysis, complete blood count, coagulation profile, liver functions test, arterial blood gas, serum lactate and daily follow up urea, creatinine, and electrolytes.
  4. ECG, echocardiography, and lung ultrasound.
  5. Volume status will be assessed by urine output, CVP, mean arterial pressure.
  6. The following work up.

    • VExUS score (IVC assessment, hepatic venous, intrarenal venous Doppler and portal vein Doppler)
    • Cardiorenal patient will receive diuretic therapy as a standard treatment in patients with VEXSUS score 1-3
    • Daily VExUS score will be done
    • Diuretic resistance will be defined as 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 patient).
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Conditions studied

  • Cardio-Renal Syndrome

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03

In context

Cardio-Renal Syndrome

76 studies on the registry are indexed under Cardio-Renal Syndrome; 22 are open to participants now.

This study's planned enrollment of 60 is below the median of 150 across 26 observational studies indexed under Cardio-Renal Syndrome.

Browse Cardio-Renal Syndrome studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Cardiorenal patients above 18 years old

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
7 Days
Patient registry
Yes

Interventions

  • OtherVExUS score

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

  • DrugDiuretic Effect

    Response to diuretic therapy

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What researchers measure

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)

    Time frame: Baseline

Secondary outcomes

  1. Length of ICU stay

    Length of ICU stay

    Time frame: Through study completion, an average of 2 weeks

  2. Worsening renal function

    Measurement of Urea and Creatinine on admission and daily follow up Follow up the fluid chart daily (urine input and output) Calculation of eGFR using Cockcroft-Gault Formula on admission daily follow up

    Time frame: Through study completion, an average of 2 weeks

  3. Need to ultrafiltration

    Patient with symptoms and signs of pulmonary congestion with failure to respond to diuretic therapy and need for ultrafiltration session

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 30852913 ↗
  • 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. PubMed 25979272 ↗
  • 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. PubMed 34146184 ↗
  • 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. PubMed 33132560 ↗
  • 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. PubMed 30429498 ↗
  • 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. PubMed 29923763 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05368766
Lead sponsor
Assiut University
Responsible party
Hany Ayad Habib Said (Principal Investigator, Assiut University) — Principal investigator
First posted
May 10, 2022
Start date
Jun 1, 2022 (estimated)
Primary completion
Jun 1, 2024 (estimated)
Completion
Aug 1, 2024 (estimated)
Last update
May 10, 2022

Study contacts

Hany A. Habib, Master
Contact
hanysaid1690@gmail.com
01010963829
Ahmad B. Abdelrehim, MD
Contact
ahmadbahie@yahoo.com
01009820300
Abdallah I. Kelany, MD
study director · university

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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