Assessment of Volume Status by Doppler US

NCT ID: NCT05115539

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-31

Study Completion Date

2023-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fluid Assessment by Doppler us Changes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

doppler US of portal vein, hepatic veins, intrarenal veins

Hepatic Vein Doppler : To obtain the HV PW, a phased array transducer is used with cardiac pre-sets. ECG leads are placed to assist in the interpretation of HVD in sinus rhythm as well as atrial fibrillation. The middle hepatic vein is identified from mid-subcostal or lateral views during the end-expiratory phase of the patients respiratory cycle.

Portal vein Doppler: From a lateral costal or subcostal window, the portal vein is identified in the coronal plane using a phased-array transducer. The PV were considered abnormal if the pulsatilty index was greater than 30%. The portal pulsatility index was defined as: (VMax - VMin/VMax) \* 100%. Here, VMax is the maximal velocity and VMin is the minimal velocity during the cardiac cycle.

Intra-renal venous Doppler: From lateral costal window, the kidney is located in the coronal plane and a color flow box placed over the distal renal calyceal junction to cortex.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Omar Zein Elabedeen Ahmed Abdallah

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohammed Alyamany Kobeisy, MD

Role: CONTACT

Phone: 01002228914

Email: [email protected]

Dina Ali Ahmed Abd El-All, MD

Role: CONTACT

Phone: 01063040703

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

Spiegel R, Teeter W, Sullivan S, Tupchong K, Mohammed N, Sutherland M, Leibner E, Rola P, Galvagno SM Jr, Murthi SB. The use of venous Doppler to predict adverse kidney events in a general ICU cohort. Crit Care. 2020 Oct 19;24(1):615. doi: 10.1186/s13054-020-03330-6.

Reference Type RESULT
PMID: 33076961 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AVSDTPAKI

Identifier Type: -

Identifier Source: org_study_id