Acute Kidney InjuryNCT04622384
The Performance of Renal Doppler Ultrasound in Predicting Outcome of Dialysis Weaning
An observational study of Acute Kidney Injury and Acute Kidney Failure Stage 3, run by Johan Fridolf Hermansen at 1 site in Denmark.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Acute Kidney Failure Stage 3
- What is being tested?
- Dialysis weaning
- How many people
- 33 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2021to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU, Aarhus University Hospital who are treated with dialysis as CRRT and planned to undergo dialysis weaning as determined their attending ICU physician.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Department of Anaesthesiology
Aarhus, 8200
About this study
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.
- Conditions
- Acute Kidney Injury, Acute Kidney Failure Stage 3
- Being tested
- Dialysis weaning
- Keywords
- Ultrasound, Renal Replacement Therapy, Dialysis, Renal Doppler Ultrasound
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialysis weaningOther
Dialysis weaning as planned by the attending ICU-physician.
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | Patients who are treated with dialysis as CRRT and planned to undergo dialysis weaning. Receives: Other: Dialysis weaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialysis weaning
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.
Measured: 7 days
Secondary outcomes (6)
Renal Doppler arterial Resistive Index (RI)
Measured in the interlobar vessels
Measured: Measured at the beginning of weaning and after 6 hours.
Renal Doppler Renal Venous Stasis Index (RVSI)
Measured in the interlobar vessels
Measured: Measured at the beginning of weaning and after 6 hours.
Renal Doppler Venous Impedance Index (VII)
Measured in the interlobar vessels
Measured: Measured at the beginning of weaning and after 6 hours.
Portal vein Doppler Pulsatility Fraction PF)
Measured in the interlobar vessels
Measured: Measured at the beginning of weaning and after 6 hours.
Urine Output
Measured: 4 days
Urine Creatinine Clearance
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Jan 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johan Fridolf Hermansen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Johan Fridolf Hermansen, Aarhus University Hospital
- Investigators
- Peter Juhl-Olsen, MD, PhD, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622384
- Sponsor's protocol ID
- 1-10-72-40-20(3)
- Status last verified
- Mar 2024
- First submitted
- 26 Oct 2020
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performance of Renal Doppler Ultrasound in Predicting Outcome of Dialysis Weaning
- ClinicalTrials.gov ID
- NCT04622384
- Acronym / sponsor ID
- 1-10-72-40-20(3)
- Conditions
- Acute Kidney Injury, Acute Kidney Failure Stage 3
- Keywords
- Ultrasound, Renal Replacement Therapy, Dialysis, Renal Doppler Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Johan Fridolf HermansenUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | Other: Dialysis weaningPatients who are treated with dialysis as CRRT and planned to undergo dialysis weaning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU, Aarhus University Hospital who are treated with dialysis as CRRT and planned to undergo dialysis weaning as determined their attending ICU physician.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialysis weaningDialysis weaning as planned by the attending ICU-physician. | Other | ICU patients |
Primary outcome
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.
6 secondary outcomes
Renal Doppler arterial Resistive Index (RI)
Time frame: 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.
Renal Doppler Venous Impedance Index (VII)
Time frame: Measured at the beginning of weaning and after 6 hours.
Portal vein Doppler Pulsatility Fraction PF)
Time frame: Measured at the beginning of weaning and after 6 hours.
Urine Output
Time frame: 4 days
Urine Creatinine Clearance
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Juhl-Olsen, MD, PhD study chair
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Acute Kidney Failure Stage 3, run by Johan Fridolf Hermansen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dialysis weaning (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.