- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04622384
The Performance of Renal Doppler Ultrasound in Predicting Outcome of Dialysis Weaning
Acute kidney injury (AKI) is a frequent problem in the intensive care unit (ICU) affecting more than 50 % of patients. AKI is associated with several adverse outcomes, including increased mortality and increased length of ICU- and hospital stay, in particular in patients requiring Renal Replacement Therapy (RRT).
Choosing the optimal time for attempting liberation from RRT is still unclear. With this study, we will describe the ability of renal ultrasound in predicting the outcome of dialysis weaning.
Study Overview
Status
Conditions
Intervention / Treatment
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
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients ≥ 18 years admitted to the ICU, Aarhus University Hospital who are treated with dialysis as continuous renal placement therapy (CRRT) and planned to undergo dialysis weaning
Exclusion Criteria:
- Insufficient ultrasonographic imaging of the kidneys
- Known morphological kidney disease
- Previous need of chronic RRT
- Prior participation in the study
- Need of extracorporeal membrane oxygenation (ECMO) or other heart assist device
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ICU patients
Patients who are treated with dialysis as CRRT and planned to undergo dialysis weaning.
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Dialysis weaning as planned by the attending ICU-physician.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dialysis weaning
Time Frame: 7 days
|
If discontinuation of Dialysis is successful or not.
Successful dialysis weaning is defined as no renal replacement therapy (RRT) required within the first 7 days after stopping continuous renal replacement therapy (CRRT) and non-successful weaning as the need for RRT within the first 7 days.
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7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Renal Doppler arterial Resistive Index (RI)
Time Frame: Measured at the beginning of weaning and after 6 hours.
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Measured in the interlobar vessels
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Measured at the beginning of weaning and after 6 hours.
|
|
Renal Doppler Renal Venous Stasis Index (RVSI)
Time Frame: Measured at the beginning of weaning and after 6 hours.
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Measured in the interlobar vessels
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Measured at the beginning of weaning and after 6 hours.
|
|
Renal Doppler Venous Impedance Index (VII)
Time Frame: Measured at the beginning of weaning and after 6 hours.
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Measured in the interlobar vessels
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Measured at the beginning of weaning and after 6 hours.
|
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Portal vein Doppler Pulsatility Fraction PF)
Time Frame: Measured at the beginning of weaning and after 6 hours.
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Measured in the interlobar vessels
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Measured at the beginning of weaning and after 6 hours.
|
|
Urine Output
Time Frame: 4 days
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4 days
|
|
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Urine Creatinine Clearance
Time Frame: 4 days
|
4 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Peter Juhl-Olsen, MD, PhD, Aarhus University Hospital
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
- 1-10-72-40-20(3)
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
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