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Correlation Between Monitoring Renal Hemodynamics by Esophageal Ultrasound and Acute Kidney Injury After Heart Surgery

4 de enero de 2019 actualizado por: Jin Dong Liu, Xuzhou Medical University

Correlation Between Monitoring Renal Hemodynamics by Esophageal Ultrasound and Acute Kidney Injury After Heart Surgery.

Acute kidney injury (AKI) is a common complication of cardiac surgery, which seriously affects the postoperative complication rate and mortality of patients.Acute kidney injury occurs in 5-30% of patients after cardiac surgery, but severe acute kidney injury requiring dialysis is relatively rare.At present, the diagnosis of AKI is based on serum creatinine (Scr) or urine volume. However, the changes of serum creatinine value have hysteresis, and the increase of serum creatinine level lags behind kidney injury for 48 ~ 72 h.Some drugs can also affect creatinine levels.Urine volume is also affected by many factors.Due to the lack of sensitivity and specificity of SCr, it is very important to find and adopt new early AKI markers.Kidney is an important metabolic organ of human body. Different from cerebrovascular system, kidney lacks automatic regulation ability and is easily affected by perfusion flow.Previous experiments have shown that placing a multi-plane esophageal probe into the human stomach through the esophagus can monitor the changes of left renal blood flow before, during and after cardiovascular surgery extracorporeal circulation, and has good repeatability, which may become an effective means to monitor renal blood flow during cardiovascular surgery.

In conclusion, this study intends to use esophageal ultrasound as a means to monitor renal blood flow, observe the changes of intraoperative renal hemodynamic indexes, and use KDIGO ( Kidney Disease:Improving Global Outcomes)as the standard of renal injury to explore the correlation between intraoperative hemodynamic changes and postoperative AKI, providing a new perspective for the pathophysiological study of AKI after cardiopulmonary bypass.

Descripción general del estudio

Estado

Desconocido

Descripción detallada

The mechanism of acute kidney injury after CPB has not been fully elucidated, and current studies suggest that the main mechanisms are as follows:

(1) endogenous/exogenous nephrotoxic substances;(2) metabolic factors: mainly reflected in the preoperative status of patients, such as obesity, low body weight, etc.;(3) hemodynamic factors: hemodynamic instability is an important mechanism for further renal injury process such as ischemia reperfusion, which is mainly reflected in: a.preoperative and postoperative hypotension: cardiogenic shock caused by cardiac insufficiency and low cardiac displacement;Non-cardiogenic shock (vasoactive drugs/allergies/postoperative bleeding);b. hemodynamic instability of intraoperative intervention: deep anesthesia, intraoperative blood loss, CPB-related intraoperative low perfusion (long CPB time, low circulation flow, low mean arterial pressure in CPB), embolic release (atherosclerotic emboli/air emboli), aorta and distal arteriotomy;(4) neurohumoral system factors: hormones such as epinephrine, norepinephrine, renin and thyroxine change to varying degrees during cardiac surgery and CPB, thus affecting the body state and systemic blood vessels;(5) inflammation and oxidative stress.

Kidney is an important metabolic organ of human body. Different from cerebrovascular system, kidney lacks automatic regulation ability and is easily affected by perfusion flow.For patients at high risk of postoperative acute kidney injury, appropriate intraoperative perfusion may reduce the incidence of postoperative acute kidney injury.

Esophageal ultrasound was used as a means of monitoring renal blood flow to observe the changes in intraoperative renal hemodynamic indexes. Meanwhile, KDIGO was used as the standard for renal injury. AKI was divided into two groups according to whether postoperative AKI occurred, and the correlation between intraoperative hemodynamic changes and postoperative AKI in the two groups was discussed.It provides new ideas for the early diagnosis of postoperative acute kidney injury.

Tipo de estudio

De observación

Inscripción (Anticipado)

60

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

60 patients undergoing elective cardiac surgery in the Affiliated Hospital of Xuzhou Medical University.

Descripción

Inclusion Criteria:

  • Aged between 18 and 70;
  • Elective cardiopulmonary bypass for patients undergoing cardiac surgery

Exclusion Criteria:

  • Acute myocardial infarction surgery within 7 days
  • Emergency surgery
  • Known renal artery stenosis, renal malformation;Renal failure
  • Congenital esophageal malformation
  • Patients with previous history of stomach and esophagus should avoid intraoperative esophageal ultrasound examination
  • Existing acute kidney injury, kidney transplantation, chronic kidney disease and glomerular filtration rate less than 30 ml/min,
  • Pregnancy

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
AUC(RI)
Periodo de tiempo: RI monitored 30 minutes after cardiopulmonary bypass termination
ROC curve(receiver operating characteristic curve)will be drawn according to the incidence of renal resistance index (RI) monitored by TEE and the incidence of postoperative AKI in patients, and AUC value(Area Under Curve) will be statistically analyzed.
RI monitored 30 minutes after cardiopulmonary bypass termination
AUC(PI)
Periodo de tiempo: PI monitored 30 minutes after cardiopulmonary bypass termination
ROC curve will be drawn according to the incidence of renal pulsatility index (PI) monitored by TEE and the incidence of postoperative AKI in patients, and AUC value will be statistically analyzed.
PI monitored 30 minutes after cardiopulmonary bypass termination

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in biomarkers
Periodo de tiempo: Before surgery and at 4 hours, 12 hours, and 24 hours after surgery
Analysis of insulin-like growth factor-binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases-2 (TIMP-2) concentrations (both induction factors for G1 cell cycle arrest are associated with acute kidney injury and are predicted as biomarkers).
Before surgery and at 4 hours, 12 hours, and 24 hours after surgery
Length of ICU stay
Periodo de tiempo: an average of 2 days
All patients are routinely transferred to ICU after surgery
an average of 2 days
Length of hospital stay
Periodo de tiempo: an average of 10 days
All patients are routinely transferred to ICU after surgery
an average of 10 days
Use of renal replacement therapy
Periodo de tiempo: Until 3 months after discharge
The use of postoperative renal replacement therapy depends on the diagnosis and treatment of ICU staff.
Until 3 months after discharge
Survival rate
Periodo de tiempo: At 1, 7 and 30 days after discharge
Record the survival rate after hospital discharged.
At 1, 7 and 30 days after discharge

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Director de estudio: Jin Dong Liu, M.S, The Affiliated Hospital of Xuzhou Medical University

Publicaciones y enlaces útiles

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Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Anticipado)

2 de enero de 2019

Finalización primaria (Anticipado)

30 de agosto de 2019

Finalización del estudio (Anticipado)

30 de septiembre de 2019

Fechas de registro del estudio

Enviado por primera vez

1 de enero de 2019

Primero enviado que cumplió con los criterios de control de calidad

4 de enero de 2019

Publicado por primera vez (Actual)

9 de enero de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de enero de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

4 de enero de 2019

Última verificación

1 de diciembre de 2018

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • XYFY-2018-0008

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

Individual Participant Data(IPD) will be available when this trial is finished and the article have been published.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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