CClinicalTrials.gg
TerminatedNCT04198168Updated Dec 9, 2020

The Predictive Performance of Renal Ultrasound on Changes in Renal Clearance

An observational study in Acute Kidney Injury, Hypoperfusion and Fluid Overload, sponsored by Aarhus University Hospital. Terminated at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-09.

Sponsored by Aarhus University Hospital · Observational

Why this study was terminated
Due to the COVID-19 situation, it was not feasible to complete the study in our ICU.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Kidney Injury
  • Hypoperfusion
  • Fluid Overload

Browse trials for

Keywords

  • Ultrasound
  • Renal perfusion
  • Fluid treatment
  • Venous congestion
  • Renal function
03

In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 2 is below the median of 150 across 773 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

All patients admitted to the ICU at Aarhus University Hospital

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

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DrugIV crystalloid fluid bolus

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

06

What researchers measure

Primary outcomes

  1. Changes in renal function in response to a standardised fluid bolus.

    Renal function is measures as Tc-99-Diethylenetriaminepentaacetic acid (DTPA) clearance.

    Time frame: 6 hours

Secondary outcomes

  1. Renal venous flow classification

    normal - abnormal (pulsatile/biphasic/monophasic

    Time frame: 6 hours

  2. Renal venous impedance index

    (maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity

    Time frame: 6 hours

  3. Renal venous stasis index

    (index cardiac cycle time - venous flow time) / index cardiac cycle time

    Time frame: 6 hours

  4. Renal arterial resistive index

    (maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity

    Time frame: 6 hours

  5. Portal venous pulsatility fraction

    (maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity

    Time frame: 6 hours

  6. Contrast enhanced ultrasound 1

    Mean transit time (mTT)

    Time frame: 6 hours

  7. Contrast enhanced ultrasound 2

    Perfusion Index (PI)

    Time frame: 6 hours

  8. Contrast enhanced ultrasound 3

    Relative Blood Volume (rBV)

    Time frame: 6 hours

  9. Contrast enhanced ultrasound 4

    Wash-in Rate (WiR)

    Time frame: 6 hours

  10. Contrast enhanced ultrasound 5

    Quality Of Fit (QOF)

    Time frame: 6 hours

  11. Continuous recordings of hemodynamic variables 1

    arterial pressure

    Time frame: 6 hours

  12. Continuous recordings of hemodynamic variables 2

    Central venous pressure

    Time frame: 6 hours

07

Study locations

1 site
  • Aarhus University Hospital, Department of Anaesthesiology
    Aarhus, 8200, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04198168
Lead sponsor
Aarhus University Hospital
Responsible party
Johan Fridolf Hermansen (Principal Investigator, Aarhus University Hospital) — Principal investigator
First posted
Dec 13, 2019
Start date
Jan 1, 2020
Primary completion
Nov 30, 2020
Completion
Nov 30, 2020
Last update
Dec 9, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion