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WithdrawnNCT03974347

New Methods for Early Detection of Acute Kidney Injury After Heart Surgery

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
Karolinska Institutet · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

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: 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

Timeline

Start date
2025-01-01
Primary completion
2025-09-01
Completion
2026-09-01
First posted
2019-06-04
Last updated
2025-09-03

Source: ClinicalTrials.gov record NCT03974347. Inclusion in this directory is not an endorsement.