New Methods for Early Detection of Acute Kidney Injury After Heart Surgery
NCT ID: NCT03974347
Last Updated: 2025-09-03
Study Results
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Basic Information
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WITHDRAWN
OBSERVATIONAL
2025-01-01
2026-09-01
Brief Summary
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Detailed Description
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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:
1. 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.
2. 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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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 interventions assigned to this group
No Acute Kidney Injury
No Acute kidney Injury after Cardiac surgery, according to KDIGO AKI definition
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Previously received a renal transplant
* Renal failure requiring dialysis prior to surgery
* Persistent atrial fibrillation
18 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Max Bell
Associate Professor
Principal Investigators
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Max Bell, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Daniel Hertberg, MD, PHD
Role: STUDY_DIRECTOR
Karolinska Institutet
References
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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.
Le 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.
Ryden 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.
Hertzberg 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.
Ryden 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.
Other Identifiers
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2019-02319
Identifier Type: -
Identifier Source: org_study_id
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