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

May 6, 2022 updated by: Hany Ayad Habib Said, Assiut University
To assess predictive value of venous excess ultrasound score in cardiorenal patient management

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cardiorenal patients above 18 years old

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
response to diuretic
Time Frame: Baseline
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of ICU stay
Time Frame: Through study completion, an average of 2 weeks
Length of ICU stay
Through study completion, an average of 2 weeks
Worsening renal function
Time Frame: Through study completion, an average of 2 weeks
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
Through study completion, an average of 2 weeks
Need to ultrafiltration
Time Frame: Baseline
Patient with symptoms and signs of pulmonary congestion with failure to respond to diuretic therapy and need for ultrafiltration session
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Abdallah I. Kelany, MD, University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VExUS score in cardiorenal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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