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The Predictive Performance of Renal Ultrasound on Changes in Renal Clearance

The Predictive Performance of Renal Ultrasonographic Perfusion Measures on Changes in Renal Clearance in Response to Fluid Therapy.

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04198168
Enrollment
2
Registered
2019-12-13
Start date
2020-01-01
Completion date
2020-11-30
Last updated
2020-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Fluid Overload, Hypoperfusion

Keywords

Ultrasound, Renal perfusion, Fluid treatment, Venous congestion, Renal function

Brief summary

The study will examine the ability of renal ultrasound (Doppler and Contrast Enhanced Ultrasound (CEUS)) in distinguishing ICU patients who exhibit increases in glomerular filtration rate (GFR) in response to fluid loading, from those for whom fluid loading is without benefit of directly harmful.

Detailed description

The study will examine the ability of renal ultrasound (Doppler and Contrast Enhanced Ultrasound (CEUS)) in distinguishing ICU patients who exhibit increases in GFR in response to fluid loading, from those for whom fluid loading is without benefit of directly harmful. Patients available for inclusion will receive a baseline administration of Tc-99-DTPA for precise determination of GFR/renal function by blood and urine samples. Baseline values of ultrasound measures will be obtained, including renal arterial, renal venous, portal venous and hepatic venous Doppler measures and renal contrast enhanced ultrasound (CEUS) will also be recorded. After two hours, baseline values of GFR are finished. The patient is then exposed to passive leg raising and ultrasound measures are repeated, including renal arterial, renal venous, portal venous and hepatic venous Doppler measures. The participant then receives a standardised fluid bolus of 7 ml/kg (ideal body weight) Once the fluid bolus administration is complete, renal ultrasound is repeated, including renal arterial, renal venous, portal venous, hepatic venous Doppler measures and renal CEUS. Follow-up determination of GFR/renal function based on Tc-99-DTPA after fluid therapy is repeated with blood and urine samples.

Interventions

DRUGIV crystalloid fluid bolus

The participant receives IV fluid as a standardised bolus of 7 ml/kg (ideal body weight).

Sponsors

Aarhus University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Patients ≥ 18 years admitted to the ICU, Aarhus University Hospital. * Patients who are assessed by their attending physician as having need for fluid therapy.

Exclusion criteria

* Insufficient ultrasound imaging of the kidneys. * Pregnancy. * Intolerance to any ultrasound contrast agent or isotopes, including intolerance for human albumin. * Prior enrolment in a conflicting research study. * Known morphological kidney disease. * Need for dialysis. * Need for extracorporeal membrane oxygenation (ECMO). * Prior participation. * Severe pulmonary hypertension (systolic pulmonary pressure \> 90 mmHg)

Design outcomes

Primary

MeasureTime frameDescription
Changes in renal function in response to a standardised fluid bolus.6 hoursRenal function is measures as Tc-99-Diethylenetriaminepentaacetic acid (DTPA) clearance.

Secondary

MeasureTime frameDescription
Renal venous impedance index6 hours(maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity
Renal venous stasis index6 hours(index cardiac cycle time - venous flow time) / index cardiac cycle time
Renal arterial resistive index6 hours(maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity
Portal venous pulsatility fraction6 hours(maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity
Contrast enhanced ultrasound 16 hoursMean transit time (mTT)
Renal venous flow classification6 hoursnormal - abnormal (pulsatile/biphasic/monophasic
Contrast enhanced ultrasound 36 hoursRelative Blood Volume (rBV)
Contrast enhanced ultrasound 46 hoursWash-in Rate (WiR)
Contrast enhanced ultrasound 56 hoursQuality Of Fit (QOF)
Continuous recordings of hemodynamic variables 16 hoursarterial pressure
Continuous recordings of hemodynamic variables 26 hoursCentral venous pressure
Contrast enhanced ultrasound 26 hoursPerfusion Index (PI)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026