Acute Kidney Injury After Cardiac Surgery: Novel Ultrasound Techniques for Prediction of Acute Kidney Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03727204|
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
|Condition or disease||Intervention/treatment|
|Acute Kidney Injury Acute Renal Failure Cardiac Surgery||Procedure: On-pump cardiac surgery|
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, 4th and 28th postoperative day. In addition, patients are followed with markers of kidney function, fluid balance and invasive measures of mean arterial pressure and central venous pressure.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||1 Month|
|Official Title:||Acute Kidney Injury After Cardiac Surgery: Novel Ultrasound Techniques for Prediction of Acute Kidney Injury|
|Actual Study Start Date :||October 15, 2018|
|Estimated Primary Completion Date :||October 1, 2020|
|Estimated Study Completion Date :||October 30, 2020|
Patients undergoing cardiac surgery
On-pump cardiac surgery at Aarhus University Hospital
Procedure: On-pump cardiac surgery
All participants will undergo on-pump cardiac surgery
- 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.
- Correlation between changes in organ-specific flow measurements and the corresponding biomarkers. [ Time Frame: 1 month ]Correlations between organ-specific ultrasonography flow measurements and the corresponding biomarkers of kidneys, liver and heart function, for both absolute values of organ-specific flow and perioperative changes in organ-specific flow
- Establishment of the most optimal organ specific cut-off values and the development of AKI. [ Time Frame: 1 month ]
Establishment of the most optimal cut-off (threshold) values for
- absolute ultrasonography flow values for respectively kidney arterial flow; kidney venous flow; liver vein flow; portal vein flow and the risk of development of AKI.
- changes in ultrasonography flow values for respectively kidney arterial flow; kidney venous flow; liver vein flow; portal vein flow and the risk of development of AKI.
- Fluid balance and AKI [ Time Frame: 1 month ]Correlations between accumulated fluid balance on the 1st postoperative day and the development of AKI on the 4th postoperative day.
- Diastolic dysfunction and AKI [ Time Frame: 1 month ]Correlations between echocardiographic measures of diastolic dysfunction and AKI. The measures include mitral inflow (E and A), mitral annular motion, medíal and lateral (e' and a'), and measures define grades of diastolic dysfunction from normal to grade I-III, with grade III being the worst.
- Organ-specific flow measures and mortality [ Time Frame: 1 month ]Correlation between organ-specific ultrasonography flow measurements on the day before surgery, the 1st and 4th postoperative day and the mortality at the 1st, 4th and 28th postoperative day.
- Organ-specific flow measures and and time of stay in ICU and hospital [ Time Frame: 1 month ]Correlation between organ-specific ultrasonography flow measurements on the day before surgery, the 1st and 4th postoperative day and the duration of intensive care stay and duration of hospital stay.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727204
|Contact: Johan F Hermansen, MD||+ 45 50 73 63 email@example.com|
|Contact: Peter Juhl-Olsen, MD, PhD||+ 45 30 91 10 firstname.lastname@example.org|
|Aarhus University Hospital, Department of Anaesthesiology||Recruiting|
|Aarhus, Denmark, 8200|
|Contact: Johan F Hermansen, MD + 45 50 73 63 22 email@example.com|
|Contact: Peter Juhl-Olsen, MD, PhD + 45 30 91 10 62 firstname.lastname@example.org|
|Study Chair:||Peter Juhl-Olsen, MD, PhD||Department of Anaesthesiology, Aarhus University Hospital|