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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03974347
Enrollment
0
Registered
2019-06-04
Start date
2025-01-01
Completion date
2026-09-01
Last updated
2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

cardiac surgery, renal resistive index, creatinine clearance

Brief 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).

Interventions

None listed

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Unable to give consent * Previously received a renal transplant * Renal failure requiring dialysis prior to surgery * Persistent atrial fibrillation

Design outcomes

Primary

MeasureTime frameDescription
Acute Kidney Injury48 hoursAcute Kidney Injury defined by KDiGO criteria

Secondary

MeasureTime frameDescription
30 day Mortality30 daysDeath occurring up to 30 days after cardiac surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026