Assessment of Volume Status by Doppler US

October 30, 2021 updated by: Omar Zein Elabedeen Ahmed Abdallah, Assiut University

Assessment of Volume Status by Doppler Ultrasound to Predict Acute Kidney Injury in Critically Ill Patients

Fluid are used to increase cardiac output (CO) and blood pressure in patients admitted to the intensive care unit (ICU) .Fluid is an important line of therapy that needed in shocked patient, hypovolemic and following surgery to correct the volume state and avoid acute kidney injury. However, excess fluid administration may be harmful leading itself to increase rates of acute kidney injury (AKI), prolonged days of mechanical ventilation and death . Excess fluid administration may increase right and left atrial pressure leading to congestion and edema.

Study Overview

Detailed Description

Increasing cardiac output more than 15% following fluid administration was used as fluid responsiveness method by the Surviving Sepsis Campaign (SSC) guidelines. However, these strategies may promote over-resuscitation as most recommend continuing fluid administration until the patients are no longer VR. VR-based strategies do not assess elevations in right atrial pressure (RAP) or assess for venous congestion which could occur earlier.

The elevations of left atrial pressure can be seen clinically with hypoxia, cephalization on chest X-ray and B-lines on ultrasound resulting from pulmonary edema, while the elevation in right-sided pressure is much more difficult to detect.

It is possible that rightsided venous flow changes detect clinically important elevations in right atrial pressure that lead to venous congestion and end organ injury . Doppler flow patterns of hepatic veins (HV), portal vein (PV) and intra-renal veins (RV) are noninvasive and accurately identify early stages of right-sided venous congestion in patients who have cardiac dysfunction and congestive heart failure with elevated right atrial pressures . If HV, PV and RV can be validated as reliable measures of elevated RAP, such indicators might have utility in modulating fluid resuscitation in other critically ill patient populations.

Study Type

Observational

Enrollment (Anticipated)

100

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 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

- Adult patients who admitted to critical care unit and intermediate critical care unit of Internal medicine department after obtaining consent

Description

Inclusion Criteria:

  • - Adult patients who admitted to critical care unit and intermediate critical care unit of Internal medicine department after obtaining consent.

Exclusion Criteria:

  • 1- Children below 18 yr. 2- Patients could not be scanned within 24-h after ICU admission. 3- Patients with transplanted kidney or liver. 4- Patients with end stage renal disease.

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: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Doppler flow patterns of hepatic veins (HV), portal vein (PV) and intra-renal veins (RV) in critically ill patients and their relations to the patients' volume state.
Time Frame: 1 year
hepatic veins (HV), portal vein (PV) and intra-renal veins doppler changes in critically ill patients
1 year

Collaborators and Investigators

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

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

October 30, 2021

First Submitted That Met QC Criteria

October 30, 2021

First Posted (Actual)

November 10, 2021

Study Record Updates

Last Update Posted (Actual)

November 10, 2021

Last Update Submitted That Met QC Criteria

October 30, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • AVSDTPAKI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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