Fluid Assessment by Doppler us ChangesNCT05115539
Assessment of Volume Status by Doppler US
An observational study of Fluid Assessment by Doppler us Changes, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Assessment by Doppler us Changes
- What is being tested?
- doppler US of portal vein, hepatic veins, intrarenal veins
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - Adult patients who admitted to critical care unit and intermediate critical care unit of Internal medicine department after obtaining consent
Who may be able to join
- - Adult patients who admitted to critical care unit and intermediate critical care unit of Internal medicine department after obtaining consent.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fluid Assessment by Doppler us Changes
- Being tested
- doppler US of portal vein, hepatic veins, intrarenal veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doppler US of portal vein, hepatic veins, intrarenal veinsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
hepatic veins (HV), portal vein (PV) and intra-renal veins doppler changes in critically ill patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study startDec 2021 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fluid Assessment by Doppler us ChangesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Zein Elabedeen Ahmed Abdallah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115539
- Sponsor's protocol ID
- AVSDTPAKI
- Status last verified
- Oct 2021
- First submitted
- 30 Oct 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33076961
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Volume Status by Doppler Ultrasound to Predict Acute Kidney Injury in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05115539
- Acronym / sponsor ID
- AVSDTPAKI
- Conditions
- Fluid Assessment by Doppler us Changes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Adult patients who admitted to critical care unit and intermediate critical care unit of Internal medicine department after obtaining consent
Key inclusion criteria (1 listed)
- - Adult patients who admitted to critical care unit and intermediate critical care unit of Internal medicine department after obtaining consent.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doppler US of portal vein, hepatic veins, intrarenal veinsHepatic 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. | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Results publication: PubMed 33076961Spiegel 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Assessment by Doppler us Changes, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Alyamany Kobeisy, MD (01002228914, mohamed.hussien10@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05115539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.