The Predictive Performance of Renal Ultrasound on Changes in Renal Clearance

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04198168
• Other study ID #: 1-10-72-75-19
• Status: Terminated
• Start date: January 1, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: December 2020
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Fluid Overload
• Hypoperfusion

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Anaesthesiology	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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