New Methods for Early Detection of Acute Kidney Injury After Heart Surgery
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|ClinicalTrials.gov Identifier: NCT03974347|
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : June 6, 2019
|Condition or disease|
|Acute Kidney Injury|
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 Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||New Methods for Early Detection of Acute Kidney Injury After Heart Surgery|
|Estimated Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||September 1, 2022|
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
- Acute Kidney Injury [ Time Frame: 48 hours ]Acute Kidney Injury defined by KDiGO criteria
- 30 day Mortality [ Time Frame: 30 days ]Death occurring up to 30 days after cardiac surgery
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974347
|Contact: Mårten Renberg, MDfirstname.lastname@example.org|
|Contact: Claire Stigare, MD, PhDemail@example.com|
|Principal Investigator:||Max Bell, MD, PHD||Karolinska Institutet|
|Study Director:||Daniel Hertberg, MD, PHD||Karolinska Institutet|