Clinical trial NCT03727204: Acute Kidney Injury After Cardiac Surgery: Novel Ultrasound Techniques for Prediction of Acute Kidney Injury
Official title: Acute Kidney Injury After Cardiac Surgery: Novel Ultrasound Techniques for Prediction of Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Acute Renal Failure
Cardiac Surgery
Keywords: Ultrasound
Ultrasonographic flow measures
Fluid treatment
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2018-11-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for on-pump cardiac surgery at the Department of Cardiothoracic \& vascular surgery, Aarhus University Hospital. The study will include 100 patients from Denmark.

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.

Eligibility criteria: Inclusion Criteria:

* All patients ≥ 18 years
* Scheduled for on-pump cardiac surgery
* Oral and written consent

AND

* 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;
  * Surgery:

    * Combined CABG and valve surgery;
    * Any valve surgery except isolated aortic-valve surgery;
    * Redo surgery;
    * Endocarditis;
  * Peripheral vascular disease.

Exclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: 4 days
Secondary outcomes:
measure: Correlation between changes in organ-specific flow measurements and the corresponding biomarkers.
timeFrame: 1 month
measure: Establishment of the most optimal organ specific cut-off values and the development of AKI.
timeFrame: 1 month
measure: Fluid balance and AKI
timeFrame: 1 month
measure: Diastolic dysfunction and AKI
timeFrame: 1 month
measure: Organ-specific flow measures and mortality
timeFrame: 1 month
measure: Organ-specific flow measures and and time of stay in ICU and hospital
timeFrame: 1 month
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Anaesthesiology
city: Johannesburg
country: South Africa
facility: Department of Anesthesiology, Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand
Study officials:
affiliation: Department of Anaesthesiology, Aarhus University Hospital
name: Peter Juhl-Olsen, MD, PhD
role: STUDY_CHAIR
References: