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Clinical Trials/NCT03727204
NCT03727204
Completed
Not Applicable

Acute Kidney Injury After Cardiac Surgery: Novel Ultrasound Techniques for Prediction of Acute Kidney Injury

Aarhus University Hospital2 sites in 2 countries150 target enrollmentOctober 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
Aarhus University Hospital
Enrollment
150
Locations
2
Primary Endpoint
The association between the kidney venous ultrasonography flow pattern category on the 1st postoperative day and acute kidney injury (AKI) on the 4th postoperative day.
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Acute Kidney Injury (AKI) is a frequent and important complication to cardiac surgery. This study will evaluate the diagnostic ability of ultrasonographic measures of blood flow in kidneys and liver in predicting AKI after cardiac surgery.

Detailed Description

Acute Kidney Injury (AKI) is a frequent and important complication to cardiac surgery. The pathophysiology is multifactorial, but renal functions in this setting is determined by a complex interplay between renal perfusion, fluid status, cardiac output, mean arterial pressure and back pressure to venous outflow. Renal perfusion may be quantified with novel ultrasound techniques. Ultrasonography of the kidney and renal vasculature allows for assessment of renal afferent flow and renal venous flow and, together with venous flow patterns of the portal vein and liver veins, may identify patients in risk of AKI. The study is observational and will describe the diagnostic accuracy of the ultrasound measures in predicting postoperative AKI. Patients will be examined with ultrasound of kidney and liver flow along with echocardiography on on the day before surgery and on the 1st and 4th. In addition, patients are followed with markers of kidney function, fluid balance and invasive measures of mean arterial pressure and central venous pressure.

Registry
clinicaltrials.gov
Start Date
October 15, 2018
End Date
March 31, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Aarhus University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Johan Fridolf Hermansen

Principal Investigator

Aarhus University Hospital

Eligibility Criteria

Inclusion Criteria

  • All patients ≥ 18 years
  • Scheduled for on-pump cardiac surgery
  • Oral and written consent
  • 1 of the following risk factors for development of postoperative AKI may be included:
  • age \> 70 years;
  • NYHA (New York Heart Association) 3+4;
  • Insulin dependent diabetes;
  • Glomerular filtration rate \< 60 ml/min/1,73 m2;
  • Ejection fraction \< 35;
  • Combined CABG and valve surgery;

Exclusion Criteria

  • Insufficient ultrasonographic imaging of the kidneys;
  • Known morphological kidney disease;
  • Preoperative dialysis;
  • Prior participation in the study.

Outcomes

Primary Outcomes

The association between the kidney venous ultrasonography flow pattern category on the 1st postoperative day and acute kidney injury (AKI) on the 4th postoperative day.

Time Frame: 4 days

The flow pattern is grouped as either continuous, biphasic or monophasic based on the appearance.The final analysis will possibly include other flow categories. AKI is defined by the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria and graded in four stages from no AKI to stage 1-3 AKI based on serum creatinin change and/or changes in urine output, with stage 3 being the worst stage.

Secondary Outcomes

  • Correlation between changes in organ-specific flow measurements and the corresponding biomarkers.(1 month)
  • Diastolic dysfunction and AKI(1 month)
  • Establishment of the most optimal organ specific cut-off values and the development of AKI.(1 month)
  • Fluid balance and AKI(1 month)
  • Organ-specific flow measures and mortality(1 month)
  • Organ-specific flow measures and and time of stay in ICU and hospital(1 month)

Study Sites (2)

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