The Predictive Performance of Renal Ultrasound on Changes in Renal Clearance

Terminated

• Conditions: Fluid Overload; Acute Kidney Injury; Hypoperfusion
• Interventions: Drug: IV crystalloid fluid bolus

• Registration Number: NCT04198168
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Study Start: 2020-01-01
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-07
• Last Update Posted: 2020-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU patients	IV crystalloid fluid bolus	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.

Primary Outcome Measures

Name	Time	Method
Changes in renal function in response to a standardised fluid bolus.	6 hours	Renal function is measures as Tc-99-Diethylenetriaminepentaacetic acid (DTPA) clearance.

Secondary Outcome Measures

Name	Time	Method
Renal venous flow classification	6 hours	normal - abnormal (pulsatile/biphasic/monophasic
Contrast enhanced ultrasound 5	6 hours	Quality Of Fit (QOF)
Renal venous stasis index	6 hours	(index cardiac cycle time - venous flow time) / index cardiac cycle time
Renal arterial resistive index	6 hours	(maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity
Contrast enhanced ultrasound 3	6 hours	Relative Blood Volume (rBV)
Portal venous pulsatility fraction	6 hours	(maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity
Contrast enhanced ultrasound 1	6 hours	Mean transit time (mTT)
Contrast enhanced ultrasound 2	6 hours	Perfusion Index (PI)
Renal venous impedance index	6 hours	(maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity
Contrast enhanced ultrasound 4	6 hours	Wash-in Rate (WiR)
Continuous recordings of hemodynamic variables 1	6 hours	arterial pressure
Continuous recordings of hemodynamic variables 2	6 hours	Central venous pressure

Trial Locations

Locations (1)

Aarhus University Hospital, Department of Anaesthesiology; 🇩🇰 Aarhus, Denmark