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Clinical Trials/NCT03798067
NCT03798067
Unknown
Not Applicable

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

Xuzhou Medical University0 sites60 target enrollmentJanuary 2, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Acute Kidney Injury
Sponsor
Xuzhou Medical University
Enrollment
60
Primary Endpoint
AUC(RI)
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 2, 2019
End Date
September 30, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Xuzhou Medical University
Responsible Party
Principal Investigator
Principal Investigator

Jin Dong Liu

Principal Investigator

Xuzhou Medical University

Eligibility Criteria

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

Outcomes

Primary Outcomes

AUC(RI)

Time Frame: 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.

AUC(PI)

Time Frame: 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.

Secondary Outcomes

  • Length of hospital stay(an average of 10 days)
  • Changes in biomarkers(Before surgery and at 4 hours, 12 hours, and 24 hours after surgery)
  • Length of ICU stay(an average of 2 days)
  • Survival rate(At 1, 7 and 30 days after discharge)
  • Use of renal replacement therapy(Until 3 months after discharge)

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