Acute Kidney InjuryNCT03727204
Acute Kidney Injury After Cardiac Surgery: Novel Ultrasound Techniques for Prediction of Acute Kidney Injury
An observational study of Acute Kidney Injury and Acute Renal Failure, run by Aarhus University Hospital at 2 sites in 2 countries.
Trial summary
Acute Kidney Injury (AKI) is a frequent and important complication to cardiac surgery. This study will evaluate the diagnostic ability of ultrasonographic measures of blood flow in kidneys and liver in predicting AKI after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Acute Renal Failure, Cardiac Surgery
- What is being tested?
- On-pump cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Oct 2018to 31 Mar 2020
- How long will I take part?
- 1 Month
- 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 scheduled for on-pump cardiac surgery at the Department of Cardiothoracic \& vascular surgery, Aarhus University Hospital. The study will include 100 patients from Denmark.
Who may be able to join
- All patients ≥ 18 years
- Scheduled for on-pump cardiac surgery
- Oral and written consent
- AND
- 1 of the following risk factors for development of postoperative AKI may be included:
- age > 70 years;
Show all 16Show fewer
- NYHA (New York Heart Association) 3+4;
- Insulin dependent diabetes;
- Glomerular filtration rate < 60 ml/min/1,73 m2;
- Ejection fraction < 35;
- Surgery:
- Combined CABG and valve surgery;
- Any valve surgery except isolated aortic-valve surgery;
- Redo surgery;
- Endocarditis;
- Peripheral vascular disease.
Who cannot join
- Insufficient ultrasonographic imaging of the kidneys;
- Known morphological kidney disease;
- Preoperative dialysis;
- Prior participation in the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Denmark1 site
Aarhus University Hospital, Department of Anaesthesiology
Aarhus, 8200
South Africa1 site
Department of Anesthesiology, Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand
Johannesburg, 2196
About this study
Acute Kidney Injury (AKI) is a frequent and important complication to cardiac surgery. This study will evaluate the diagnostic ability of ultrasonographic measures of blood flow in kidneys and liver in predicting AKI after cardiac surgery.
Read the detailed description
Acute Kidney Injury (AKI) is a frequent and important complication to cardiac surgery. The pathophysiology is multifactorial, but renal functions in this setting is determined by a complex interplay between renal perfusion, fluid status, cardiac output, mean arterial pressure and back pressure to venous outflow.
Renal perfusion may be quantified with novel ultrasound techniques. Ultrasonography of the kidney and renal vasculature allows for assessment of renal afferent flow and renal venous flow and, together with venous flow patterns of the portal vein and liver veins, may identify patients in risk of AKI.
The study is observational and will describe the diagnostic accuracy of the ultrasound measures in predicting postoperative AKI. Patients will be examined with ultrasound of kidney and liver flow along with echocardiography on on the day before surgery and on the 1st and 4th. In addition, patients are followed with markers of kidney function, fluid balance and invasive measures of mean arterial pressure and central venous pressure.
- Conditions
- Acute Kidney Injury, Acute Renal Failure, Cardiac Surgery
- Being tested
- On-pump cardiac surgery
- Keywords
- Ultrasound, Ultrasonographic flow measures, Fluid treatment
- 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.
On-pump cardiac surgeryProcedure or surgery
All participants will undergo on-pump cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| Aarhus University Hospital | 100 patients undergoing on-pump cardiac surgery at Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand Receives: Procedure: On-pump cardiac surgery | |
| Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand | 50 patients undergpoing on-pump cardiac surgery at at Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand Receives: Procedure: On-pump cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between the kidney venous ultrasonography flow pattern category on the 1st postoperative day and acute kidney injury (AKI) on the 4th postoperative day.
The flow pattern is grouped as either continuous, biphasic or monophasic based on the appearance.The final analysis will possibly include other flow categories.
AKI is defined by the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria and graded in four stages from no AKI to stage 1-3 AKI based on serum creatinin change and/or changes in urine output, with stage 3 being the worst stage.
Measured: 4 days
Secondary outcomes (6)
Correlation between changes in organ-specific flow measurements and the corresponding biomarkers.
Correlations between organ-specific ultrasonography flow measurements and the corresponding biomarkers of kidneys, liver and heart function, for both absolute values of organ-specific flow and perioperative changes in organ-specific flow
Measured: 1 month
Establishment of the most optimal organ specific cut-off values and the development of AKI.
Establishment of the most optimal cut-off (threshold) values for
- absolute ultrasonography flow values for respectively kidney arterial flow; kidney venous flow; liver vein flow; portal vein flow and the risk of development of AKI.
- changes in ultrasonography flow values for respectively kidney arterial flow; kidney venous flow; liver vein flow; portal vein flow and the risk of development of AKI.
Measured: 1 month
Fluid balance and AKI
Correlations between accumulated fluid balance on the 1st postoperative day and the development of AKI on the 4th postoperative day.
Measured: 1 month
Diastolic dysfunction and AKI
Correlations between echocardiographic measures of diastolic dysfunction and AKI. The measures include mitral inflow (E and A), mitral annular motion, medial and lateral (e' and a'), and measures define grades of diastolic dysfunction from normal to grade I-III, with grade III being the worst.
Measured: 1 month
Organ-specific flow measures and mortality
Correlation between organ-specific ultrasonography flow measurements on the day before surgery, the 1st and 4th postoperative day and the mortality at the 1st, 4th and 28th postoperative day.
Measured: 1 month
Organ-specific flow measures and and time of stay in ICU and hospital
Correlation between organ-specific ultrasonography flow measurements on the day before surgery, the 1st and 4th postoperative day and the duration of intensive care stay and duration of hospital stay.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start15 Oct 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
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
- 150 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Johan Fridolf Hermansen, Aarhus University Hospital
- Investigators
- Peter Juhl-Olsen, MD, PhD, Study chair, Department of Anaesthesiology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727204
- Sponsor's protocol ID
- 1-10-72-267-18
- Status last verified
- Apr 2021
- First submitted
- 9 Oct 2018
- Last updated
- 13 Apr 2021
- 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 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury After Cardiac Surgery: Novel Ultrasound Techniques for Prediction of Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT03727204
- Acronym / sponsor ID
- 1-10-72-267-18
- Conditions
- Acute Kidney Injury, Acute Renal Failure, Cardiac Surgery
- Keywords
- Ultrasound, Ultrasonographic flow measures, Fluid treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 1 Nov 2018 (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 and important complication to cardiac surgery. This study will evaluate the diagnostic ability of ultrasonographic measures of blood flow in kidneys and liver in predicting AKI after cardiac surgery.
Detailed description
Acute Kidney Injury (AKI) is a frequent and important complication to cardiac surgery. The pathophysiology is multifactorial, but renal functions in this setting is determined by a complex interplay between renal perfusion, fluid status, cardiac output, mean arterial pressure and back pressure to venous outflow.
Renal perfusion may be quantified with novel ultrasound techniques. Ultrasonography of the kidney and renal vasculature allows for assessment of renal afferent flow and renal venous flow and, together with venous flow patterns of the portal vein and liver veins, may identify patients in risk of AKI.
The study is observational and will describe the diagnostic accuracy of the ultrasound measures in predicting postoperative AKI. Patients will be examined with ultrasound of kidney and liver flow along with echocardiography on on the day before surgery and on the 1st and 4th. In addition, patients are followed with markers of kidney function, fluid balance and invasive measures of mean arterial pressure and central venous pressure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aarhus University Hospital | – | Procedure: On-pump cardiac surgery100 patients undergoing on-pump cardiac surgery at Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand |
| Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand | – | Procedure: On-pump cardiac surgery50 patients undergpoing on-pump cardiac surgery at at Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for on-pump cardiac surgery at the Department of Cardiothoracic \& vascular surgery, Aarhus University Hospital. The study will include 100 patients from Denmark.
Key inclusion criteria (16 listed)
- All patients ≥ 18 years
- Scheduled for on-pump cardiac surgery
- Oral and written consent
- AND
- 1 of the following risk factors for development of postoperative AKI may be included:
Key exclusion criteria (4 listed)
- Insufficient ultrasonographic imaging of the kidneys;
- Known morphological kidney disease;
- Preoperative dialysis;
- Prior participation in the study.
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 |
|---|---|---|
| On-pump cardiac surgeryAll participants will undergo on-pump cardiac surgery | Procedure or surgery | Aarhus University Hospital, Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand |
Primary outcome
The association between the kidney venous ultrasonography flow pattern category on the 1st postoperative day and acute kidney injury (AKI) on the 4th postoperative day.
Time frame: 4 days
The flow pattern is grouped as either continuous, biphasic or monophasic based on the appearance.The final analysis will possibly include other flow categories. AKI is defined by the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria and graded in four stages from no AKI to stage 1-3 AKI based on serum creatinin change and/or changes in urine output, with stage 3 being the worst stage.
6 secondary outcomes
Correlation between changes in organ-specific flow measurements and the corresponding biomarkers.
Time frame: 1 month
Establishment of the most optimal organ specific cut-off values and the development of AKI.
Time frame: 1 month
Fluid balance and AKI
Time frame: 1 month
Diastolic dysfunction and AKI
Time frame: 1 month
Organ-specific flow measures and mortality
Time frame: 1 month
Organ-specific flow measures and and time of stay in ICU and hospital
Time frame: 1 month
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 13 Apr 2021.
- 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
Department of Anaesthesiology, Aarhus University Hospital
2 sites in 2 countries: 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 Renal Failure, run by Aarhus University Hospital at 2 sites in 2 countries.
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 16 inclusion and 4 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 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, South Africa. 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?
The association between the kidney venous ultrasonography flow pattern category on the 1st postoperative day and acute kidney injury (AKI) on the 4th postoperative day. (time frame: 4 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 13 Apr 2021.