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The Predictive Performance of Renal Ultrasound on Changes in Renal Clearance

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ClinicalTrials.gov Identifier: NCT04198168
Recruitment Status : Terminated (Due to the COVID-19 situation, it was not feasible to complete the study in our ICU.)
First Posted : December 13, 2019
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Johan Fridolf Hermansen, 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.

Condition or disease Intervention/treatment
Acute Kidney Injury Hypoperfusion Fluid Overload 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.

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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Predictive Performance of Renal Ultrasonographic Perfusion Measures on Changes in Renal Clearance in Response to Fluid Therapy.
Actual Study Start Date : January 1, 2020
Actual Primary Completion Date : November 30, 2020
Actual Study Completion Date : November 30, 2020

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).




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Renal venous flow classification [ Time Frame: 6 hours ]
    normal - abnormal (pulsatile/biphasic/monophasic

  2. Renal venous impedance index [ Time Frame: 6 hours ]
    (maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity

  3. Renal venous stasis index [ Time Frame: 6 hours ]
    (index cardiac cycle time - venous flow time) / index cardiac cycle time

  4. Renal arterial resistive index [ Time Frame: 6 hours ]
    (maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity

  5. Portal venous pulsatility fraction [ Time Frame: 6 hours ]
    (maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity

  6. Contrast enhanced ultrasound 1 [ Time Frame: 6 hours ]
    Mean transit time (mTT)

  7. Contrast enhanced ultrasound 2 [ Time Frame: 6 hours ]
    Perfusion Index (PI)

  8. Contrast enhanced ultrasound 3 [ Time Frame: 6 hours ]
    Relative Blood Volume (rBV)

  9. Contrast enhanced ultrasound 4 [ Time Frame: 6 hours ]
    Wash-in Rate (WiR)

  10. Contrast enhanced ultrasound 5 [ Time Frame: 6 hours ]
    Quality Of Fit (QOF)

  11. Continuous recordings of hemodynamic variables 1 [ Time Frame: 6 hours ]
    arterial pressure

  12. Continuous recordings of hemodynamic variables 2 [ Time Frame: 6 hours ]
    Central venous pressure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All patients admitted to the ICU at Aarhus University Hospital
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04198168


Locations
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Denmark
Aarhus University Hospital, Department of Anaesthesiology
Aarhus, Denmark, 8200
Sponsors and Collaborators
Aarhus University Hospital
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Responsible Party: Johan Fridolf Hermansen, Principal Investigator, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT04198168    
Other Study ID Numbers: 1-10-72-75-19
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johan Fridolf Hermansen, Aarhus University Hospital:
Ultrasound
Renal perfusion
Fluid treatment
Venous congestion
Renal function
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases