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.
Verified date | December 2020 |
Source | Aarhus University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | November 30, 2020 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | |
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) |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital, Department of Anaesthesiology | Aarhus |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital |
Denmark,
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 |
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