Acute Kidney InjuryNCT04198168
The Predictive Performance of Renal Ultrasound on Changes in Renal Clearance
An observational study of Acute Kidney Injury and Hypoperfusion, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Hypoperfusion, Fluid Overload
- What is being tested?
- IV crystalloid fluid bolus
- Type of treatment
- Injection or infusion
- How many people
- 2 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2020to 30 Nov 2020
- 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
- Adult, Older adult
Study population: All patients admitted to the ICU at Aarhus University Hospital
Who may be able to join
- Patients ≥ 18 years admitted to the ICU, Aarhus University Hospital.
- Patients who are assessed by their attending physician as having need for fluid therapy.
Who cannot join
- 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.
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- Need for extracorporeal membrane oxygenation (ECMO).
- Prior participation.
- Severe pulmonary hypertension (systolic pulmonary pressure > 90 mmHg)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Department of Anaesthesiology
Aarhus, 8200
About this study
Official title: The Predictive Performance of Renal Ultrasonographic Perfusion Measures on Changes in Renal Clearance in Response to Fluid Therapy.
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.
Read the 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.
- Conditions
- Acute Kidney Injury, Hypoperfusion, Fluid Overload
- Being tested
- IV crystalloid fluid bolus
- Keywords
- Ultrasound, Renal perfusion, Fluid treatment, Venous congestion, Renal function
- Medical subject headings
- Acute Kidney Injury, Edema, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV crystalloid fluid bolusDrug
The participant receives IV fluid as a standardised bolus of 7 ml/kg (ideal body weight).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: IV crystalloid fluid bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in renal function in response to a standardised fluid bolus.
Renal function is measures as Tc-99-Diethylenetriaminepentaacetic acid (DTPA) clearance.
Measured: 6 hours
Secondary outcomes (12)
Renal venous flow classification
normal - abnormal (pulsatile/biphasic/monophasic
Measured: 6 hours
Renal venous impedance index
(maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity
Measured: 6 hours
Renal venous stasis index
(index cardiac cycle time - venous flow time) / index cardiac cycle time
Measured: 6 hours
Renal arterial resistive index
(maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity
Measured: 6 hours
Portal venous pulsatility fraction
(maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity
Measured: 6 hours
Contrast enhanced ultrasound 1
Mean transit time (mTT)
Measured: 6 hours
Contrast enhanced ultrasound 2
Perfusion Index (PI)
Measured: 6 hours
Contrast enhanced ultrasound 3
Relative Blood Volume (rBV)
Measured: 6 hours
Contrast enhanced ultrasound 4
Wash-in Rate (WiR)
Measured: 6 hours
Contrast enhanced ultrasound 5
Quality Of Fit (QOF)
Measured: 6 hours
Continuous recordings of hemodynamic variables 1
arterial pressure
Measured: 6 hours
Continuous recordings of hemodynamic variables 2
Central venous pressure
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Jan 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Why it stopped: Due to the COVID-19 situation, it was not feasible to complete the study in our ICU.
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.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Fridolf Hermansen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198168
- Sponsor's protocol ID
- 1-10-72-75-19
- Status last verified
- Dec 2020
- First submitted
- 8 Nov 2019
- Last updated
- 9 Dec 2020
- 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 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Performance of Renal Ultrasonographic Perfusion Measures on Changes in Renal Clearance in Response to Fluid Therapy.
- ClinicalTrials.gov ID
- NCT04198168
- Acronym / sponsor ID
- 1-10-72-75-19
- Conditions
- Acute Kidney Injury, Hypoperfusion, Fluid Overload
- Keywords
- Ultrasound, Renal perfusion, Fluid treatment, Venous congestion, Renal function
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to the COVID-19 situation, it was not feasible to complete the study in our ICU.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 13 Dec 2019 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | Drug: IV crystalloid fluid bolusICU 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the ICU at Aarhus University Hospital
Key inclusion criteria (2 listed)
- Patients ≥ 18 years admitted to the ICU, Aarhus University Hospital.
- Patients who are assessed by their attending physician as having need for fluid therapy.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| IV crystalloid fluid bolusThe participant receives IV fluid as a standardised bolus of 7 ml/kg (ideal body weight). | Drug | ICU patients |
Primary outcome
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.
12 secondary outcomes
Renal venous flow classification
Time frame: 6 hours
Renal venous impedance index
Time frame: 6 hours
Renal venous stasis index
Time frame: 6 hours
Renal arterial resistive index
Time frame: 6 hours
Portal venous pulsatility fraction
Time frame: 6 hours
Contrast enhanced ultrasound 1
Time frame: 6 hours
Contrast enhanced ultrasound 2
Time frame: 6 hours
Contrast enhanced ultrasound 3
Time frame: 6 hours
Contrast enhanced ultrasound 4
Time frame: 6 hours
Contrast enhanced ultrasound 5
Time frame: 6 hours
Continuous recordings of hemodynamic variables 1
Time frame: 6 hours
Continuous recordings of hemodynamic variables 2
Time frame: 6 hours
Results and safety
The study was stopped early (reason given: Due to the COVID-19 situation, it was not feasible to complete the study in our ICU.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypoperfusion, run by Aarhus University Hospital 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 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 9 Dec 2020. 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 was stopped early (reason given: Due to the COVID-19 situation, it was not feasible to complete the study in our ICU.). Results are not available in the source record.
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?
Changes in renal function in response to a standardised fluid bolus. (time frame: 6 hours). 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 9 Dec 2020.