The Predictive Performance of Renal Ultrasonographic Perfusion Measures on Changes in Renal Clearance in Response to Fluid Therapy.
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Aarhus University Hospital
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Changes in renal function in response to a standardised fluid bolus.
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
ICU patients
ICU patients who are assessed by their attending physician as having need for fluid therapy and are planned to receive IV crystalloid fluid due to oliguria and/or to improve GFR.
Intervention: IV crystalloid fluid bolus (Drug)
Outcomes
Primary Outcomes
Changes in renal function in response to a standardised fluid bolus.
Time Frame: 6 hours
Renal function is measures as Tc-99-Diethylenetriaminepentaacetic acid (DTPA) clearance.
Secondary Outcomes
- Renal venous flow classification(6 hours)
- Contrast enhanced ultrasound 5(6 hours)
- Renal venous stasis index(6 hours)
- Renal arterial resistive index(6 hours)
- Contrast enhanced ultrasound 3(6 hours)
- Portal venous pulsatility fraction(6 hours)
- Contrast enhanced ultrasound 1(6 hours)
- Contrast enhanced ultrasound 2(6 hours)
- Renal venous impedance index(6 hours)
- Contrast enhanced ultrasound 4(6 hours)
- Continuous recordings of hemodynamic variables 1(6 hours)
- Continuous recordings of hemodynamic variables 2(6 hours)
Investigators
Johan Fridolf Hermansen
Principal Investigator
Aarhus University Hospital