Acute Kidney InjuryNCT03974347
New Methods for Early Detection of Acute Kidney Injury After Heart Surgery
An observational study of Acute Kidney Injury, run by Karolinska Institutet.
Trial summary
The investigators intend to study 2 new methods for the early detection of Acute Kidney Injury (AKI) after cardiac surgery and compare and combine the predictive abilities of these methods with established renal injury markers and epidemiological models to detect (AKI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Sep 2026
- 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: Elective cardiac surgery patients undergoing surgery at Karolinska University Hospital, Sweden. Patients with high risk for AKI as identified by the Clevland Clinic acute renal failure score will be identified.
Who may be able to join
- 18 years and older
- Undergoing elective cardiac surgery (Coronary artery bypass grafting, valve surgery, aortic surgery or a combination).
- Able to understand and give written consent to partake in the study
Who cannot join
- Unable to give consent
- Previously received a renal transplant
- Renal failure requiring dialysis prior to surgery
- Persistent atrial fibrillation
About this study
The investigators intend to study 2 new methods for the early detection of Acute Kidney Injury (AKI) after cardiac surgery and compare and combine the predictive abilities of these methods with established renal injury markers and epidemiological models to detect (AKI).
Read the detailed description
Acute Kidney Injury is common after Cardiac surgery and occurs in up to 20% of patients (Ref Rydén).
This study will evaluate two new methods for the early detection of acute kidney injury in 200 patients undergoing elective cardiac surgery at the Karolinska Hospital.
These methods are:
- Ultrasound based measurement of the kidneys blood flow profile measured using renal resistive index (RRI). This will be measured prior and within 4 hours post surgery. Ref Herzberg, Le Dorze.
- Urine creatinine clearance will be measured in the first four hours after cardiac surgery.
The investigators will also measure known renal injury markers in blood and urine samples post operatively. These include Neutrophil gelatinise-associated lipocalin (NGAL), tissue inhibitor of metalloproteinases (TIMP-2), Insulin-like growth factor-binding protein 7 (IGFBP7), Kidney Injury Molecule 1 (KIM-1), Nephroclear, Interleukin 18 (IL-18), Fatty acid-binding protein (L-FABP), Fibulin-1, cystatin C och albumin.
The new methods of AKI detection will be used to build a statistical model to predict AKI after cardiac surgery. We will determine whether the addition of renal injury markers and epidemiological factors known to be associated with the development of AKI (variables such as age, known chronic renal dysfunction or heart failure) can improve precision in diagnosis.
AKI will be defined by the Kidney Disease improving Global outcomes (KDIGO) criteria (Ref KDIGO KDIGO Clinical Practice Guideline for Acute Kidney Injury, Khwaja A).
- Conditions
- Acute Kidney Injury
- Keywords
- cardiac surgery, renal resistive index, creatinine clearance
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Acute kidney injury, no acute kidney injury | Acute kidney injury after cardiac surgery will be defined by KDIGO criteria, Creatinine rise from baseline and or urine production. | |
| No Acute Kidney Injury | No Acute kidney Injury after Cardiac surgery, according to KDIGO AKI definition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury
Acute Kidney Injury defined by KDiGO criteria
Measured: 48 hours
Secondary outcomes (1)
30 day Mortality
Death occurring up to 30 days after cardiac surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Jan 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Why it stopped: Logistical problmens, collisions with other studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Bell, Karolinska Institutet
- Investigators
- Max Bell, MD, PHD, Principal investigator, Karolinska InstitutetDaniel Hertberg, MD, PHD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974347
- Sponsor's protocol ID
- 2019-02319
- Other IDs
- 2019
- Status last verified
- Aug 2025
- First submitted
- 2 Jun 2019
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If the study data set is released it will be anonymized so that no personal data is retained and no individual can be identified from the data by those outside of the study.
Publications
Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
PubMed 22890468Le Dorze M, Bougle A, Deruddre S, Duranteau J. Renal Doppler ultrasound: a new tool to assess renal perfusion in critical illness. Shock. 2012 Apr;37(4):360-5. doi: 10.1097/SHK.0b013e3182467156.
PubMed 22258233Ryden L, Ahnve S, Bell M, Hammar N, Ivert T, Sartipy U, Holzmann MJ. Acute kidney injury after coronary artery bypass grafting and long-term risk of myocardial infarction and death. Int J Cardiol. 2014 Mar 1;172(1):190-5. doi: 10.1016/j.ijcard.2014.01.013. Epub 2014 Jan 22.
PubMed 24502882Hertzberg D, Ceder SL, Sartipy U, Lund K, Holzmann MJ. Preoperative Renal Resistive Index Predicts Risk of Acute Kidney Injury in Patients Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2017 Jun;31(3):847-852. doi: 10.1053/j.jvca.2016.10.006. Epub 2016 Oct 11.
PubMed 28017677Ryden LC, Sartipy U, Holzmann MJ. Acute Kidney Injury After Surgical AVR and Long-Term Risk of Death and End-Stage Renal Disease. J Am Coll Cardiol. 2015 Nov 17;66(20):2263-2264. doi: 10.1016/j.jacc.2015.08.883. No abstract available.
PubMed 26553408
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Methods for Early Detection of Acute Kidney Injury After Heart Surgery
- ClinicalTrials.gov ID
- NCT03974347
- Acronym / sponsor ID
- 2019-02319
- Conditions
- Acute Kidney Injury
- Keywords
- cardiac surgery, renal resistive index, creatinine clearance
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Logistical problmens, collisions with other studies
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 4 Jun 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 investigators intend to study 2 new methods for the early detection of Acute Kidney Injury (AKI) after cardiac surgery and compare and combine the predictive abilities of these methods with established renal injury markers and epidemiological models to detect (AKI).
Detailed description
Acute Kidney Injury is common after Cardiac surgery and occurs in up to 20% of patients (Ref Rydén).
This study will evaluate two new methods for the early detection of acute kidney injury in 200 patients undergoing elective cardiac surgery at the Karolinska Hospital.
These methods are:
- Ultrasound based measurement of the kidneys blood flow profile measured using renal resistive index (RRI). This will be measured prior and within 4 hours post surgery. Ref Herzberg, Le Dorze.
- Urine creatinine clearance will be measured in the first four hours after cardiac surgery.
The investigators will also measure known renal injury markers in blood and urine samples post operatively. These include Neutrophil gelatinise-associated lipocalin (NGAL), tissue inhibitor of metalloproteinases (TIMP-2), Insulin-like growth factor-binding protein 7 (IGFBP7), Kidney Injury Molecule 1 (KIM-1), Nephroclear, Interleukin 18 (IL-18), Fatty acid-binding protein (L-FABP), Fibulin-1, cystatin C och albumin.
The new methods of AKI detection will be used to build a statistical model to predict AKI after cardiac surgery. We will determine whether the addition of renal injury markers and epidemiological factors known to be associated with the development of AKI (variables such as age, known chronic renal dysfunction or heart failure) can improve precision in diagnosis.
AKI will be defined by the Kidney Disease improving Global outcomes (KDIGO) criteria (Ref KDIGO KDIGO Clinical Practice Guideline for Acute Kidney Injury, Khwaja A).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute kidney injury, no acute kidney injury | – | –Acute kidney injury after cardiac surgery will be defined by KDIGO criteria, Creatinine rise from baseline and or urine production. |
| No Acute Kidney Injury | – | –No Acute kidney Injury after Cardiac surgery, according to KDIGO AKI definition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective cardiac surgery patients undergoing surgery at Karolinska University Hospital, Sweden. Patients with high risk for AKI as identified by the Clevland Clinic acute renal failure score will be identified.
Key inclusion criteria (3 listed)
- 18 years and older
- Undergoing elective cardiac surgery (Coronary artery bypass grafting, valve surgery, aortic surgery or a combination).
- Able to understand and give written consent to partake in the study
Key exclusion criteria (4 listed)
- Unable to give consent
- Previously received a renal transplant
- Renal failure requiring dialysis prior to surgery
- Persistent atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute Kidney Injury
Time frame: 48 hours
Acute Kidney Injury defined by KDiGO criteria
1 secondary outcome
30 day Mortality
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Background: PubMed 22890468Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
- Background: PubMed 22258233Le Dorze M, Bougle A, Deruddre S, Duranteau J. Renal Doppler ultrasound: a new tool to assess renal perfusion in critical illness. Shock. 2012 Apr;37(4):360-5. doi: 10.1097/SHK.0b013e3182467156.
- Background: PubMed 24502882Ryden L, Ahnve S, Bell M, Hammar N, Ivert T, Sartipy U, Holzmann MJ. Acute kidney injury after coronary artery bypass grafting and long-term risk of myocardial infarction and death. Int J Cardiol. 2014 Mar 1;172(1):190-5. doi: 10.1016/j.ijcard.2014.01.013. Epub 2014 Jan 22.
- Background: PubMed 28017677Hertzberg D, Ceder SL, Sartipy U, Lund K, Holzmann MJ. Preoperative Renal Resistive Index Predicts Risk of Acute Kidney Injury in Patients Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2017 Jun;31(3):847-852. doi: 10.1053/j.jvca.2016.10.006. Epub 2016 Oct 11.
- Background: PubMed 26553408Ryden LC, Sartipy U, Holzmann MJ. Acute Kidney Injury After Surgical AVR and Long-Term Risk of Death and End-Stage Renal Disease. J Am Coll Cardiol. 2015 Nov 17;66(20):2263-2264. doi: 10.1016/j.jacc.2015.08.883. No abstract available.
- Individual participant dataSharing planned: Undecided. If the study data set is released it will be anonymized so that no personal data is retained and no individual can be identified from the data by those outside of the study.
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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.
Max Bell, MD, PHD principal investigator
Karolinska Institutet
Daniel Hertberg, MD, PHD study director
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Karolinska Institutet.
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 3 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: withdrawn, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Acute Kidney Injury (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03974347, which also lists 5 linked publications.
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 3 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.