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Clinical Trials/NCT03974347
NCT03974347WithdrawnNot Applicable

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

Karolinska Institutet0 sites200 target enrollmentStarted: January 1, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Enrollment
200
Primary Endpoint
Acute Kidney Injury

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Acute Kidney Injury

Time Frame: 48 hours

Acute Kidney Injury defined by KDiGO criteria

Secondary Outcomes

  • 30 day Mortality(30 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Max Bell

Associate Professor

Karolinska Institutet

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