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

Not yet recruiting

• Conditions: Acute Kidney Injury

• Registration Number: NCT03974347
• Lead Sponsor: Karolinska Institutet

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).

Study Timeline

• Study First Submitted: 2019-06-02
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-04
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Study Start: 2025-01-01
• Primary Completion: 2025-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury	48 hours	Acute Kidney Injury defined by KDiGO criteria

Secondary Outcome Measures

Name	Time	Method
30 day Mortality	30 days	Death occurring up to 30 days after cardiac surgery