Clinical trial NCT04198168: The Predictive Performance of Renal Ultrasound on Changes in Renal Clearance
Official title: The Predictive Performance of Renal Ultrasonographic Perfusion Measures on Changes in Renal Clearance in Response to Fluid Therapy.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Kidney Injury
Hypoperfusion
Fluid Overload
Keywords: Ultrasound
Renal perfusion
Fluid treatment
Venous congestion
Renal function
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted to the ICU at Aarhus University Hospital

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in renal function in response to a standardised fluid bolus.
timeFrame: 6 hours
Secondary outcomes:
measure: Renal venous flow classification
timeFrame: 6 hours
measure: Renal venous impedance index
timeFrame: 6 hours
measure: Renal venous stasis index
timeFrame: 6 hours
measure: Renal arterial resistive index
timeFrame: 6 hours
measure: Portal venous pulsatility fraction
timeFrame: 6 hours
measure: Contrast enhanced ultrasound 1
timeFrame: 6 hours
measure: Contrast enhanced ultrasound 2
timeFrame: 6 hours
measure: Contrast enhanced ultrasound 3
timeFrame: 6 hours
measure: Contrast enhanced ultrasound 4
timeFrame: 6 hours
measure: Contrast enhanced ultrasound 5
timeFrame: 6 hours
measure: Continuous recordings of hemodynamic variables 1
timeFrame: 6 hours
measure: Continuous recordings of hemodynamic variables 2
timeFrame: 6 hours
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Anaesthesiology
Study officials:
References: