Acute Kidney Injury After Cardiac Surgery: Novel Ultrasound Techniques for Prediction of Acute Kidney Injury
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Aarhus University Hospital
100 patients undergoing on-pump cardiac surgery at Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand
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All participants will undergo on-pump cardiac surgery
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Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand
50 patients undergpoing on-pump cardiac surgery at at Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand
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All participants will undergo on-pump cardiac surgery
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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.
Periodo de tiempo: 4 days
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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. |
4 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Correlation between changes in organ-specific flow measurements and the corresponding biomarkers.
Periodo de tiempo: 1 month
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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
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1 month
|
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Establishment of the most optimal organ specific cut-off values and the development of AKI.
Periodo de tiempo: 1 month
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Establishment of the most optimal cut-off (threshold) values for
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1 month
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Fluid balance and AKI
Periodo de tiempo: 1 month
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Correlations between accumulated fluid balance on the 1st postoperative day and the development of AKI on the 4th postoperative day.
|
1 month
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Diastolic dysfunction and AKI
Periodo de tiempo: 1 month
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Correlations between echocardiographic measures of diastolic dysfunction and AKI.
The measures include mitral inflow (E and A), mitral annular motion, medial and lateral (e' and a'), and measures define grades of diastolic dysfunction from normal to grade I-III, with grade III being the worst.
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1 month
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Organ-specific flow measures and mortality
Periodo de tiempo: 1 month
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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.
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1 month
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Organ-specific flow measures and and time of stay in ICU and hospital
Periodo de tiempo: 1 month
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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.
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1 month
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Peter Juhl-Olsen, MD, PhD, Department of Anaesthesiology, Aarhus University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1-10-72-267-18
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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