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.

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.

Study Overview

• Status: Terminated
• Conditions: Acute Kidney Injury; Fluid Overload; Hypoperfusion
• Intervention / Treatment: Drug: IV crystalloid fluid bolus

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 Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital, Department of Anaesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients admitted to the ICU at Aarhus University Hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: IV crystalloid fluid bolus; The participant receives IV fluid as a standardised bolus of 7 ml/kg (ideal body weight).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Ultrasound; Renal function; Fluid treatment; Renal perfusion; Venous congestion
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 1-10-72-75-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No