- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04198168
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Aarhus, Denmark, 8200
- Aarhus University Hospital, Department of Anaesthesiology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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?
Design Details
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.
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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.
Time Frame: 6 hours
|
Renal function is measures as Tc-99-Diethylenetriaminepentaacetic acid (DTPA) clearance.
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6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Renal venous flow classification
Time Frame: 6 hours
|
normal - abnormal (pulsatile/biphasic/monophasic
|
6 hours
|
Renal venous impedance index
Time Frame: 6 hours
|
(maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity
|
6 hours
|
Renal venous stasis index
Time Frame: 6 hours
|
(index cardiac cycle time - venous flow time) / index cardiac cycle time
|
6 hours
|
Renal arterial resistive index
Time Frame: 6 hours
|
(maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity
|
6 hours
|
Portal venous pulsatility fraction
Time Frame: 6 hours
|
(maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity
|
6 hours
|
Contrast enhanced ultrasound 1
Time Frame: 6 hours
|
Mean transit time (mTT)
|
6 hours
|
Contrast enhanced ultrasound 2
Time Frame: 6 hours
|
Perfusion Index (PI)
|
6 hours
|
Contrast enhanced ultrasound 3
Time Frame: 6 hours
|
Relative Blood Volume (rBV)
|
6 hours
|
Contrast enhanced ultrasound 4
Time Frame: 6 hours
|
Wash-in Rate (WiR)
|
6 hours
|
Contrast enhanced ultrasound 5
Time Frame: 6 hours
|
Quality Of Fit (QOF)
|
6 hours
|
Continuous recordings of hemodynamic variables 1
Time Frame: 6 hours
|
arterial pressure
|
6 hours
|
Continuous recordings of hemodynamic variables 2
Time Frame: 6 hours
|
Central venous pressure
|
6 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-10-72-75-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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