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

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ClinicalTrials.gov Identifier: NCT03798067
Recruitment Status : Not yet recruiting
First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Jin Dong Liu, Xuzhou Medical University

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.


Condition or disease
Postoperative Acute Kidney Injury

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Monitoring Renal Hemodynamics by Esophageal Ultrasound and Acute Kidney Injury After Heart Surgery.
Estimated Study Start Date : January 2, 2019
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Changes in biomarkers [ Time Frame: 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).

  2. Length of ICU stay [ Time Frame: an average of 2 days ]
    All patients are routinely transferred to ICU after surgery

  3. Length of hospital stay [ Time Frame: an average of 10 days ]
    All patients are routinely transferred to ICU after surgery

  4. Use of renal replacement therapy [ Time Frame: Until 3 months after discharge ]
    The use of postoperative renal replacement therapy depends on the diagnosis and treatment of ICU staff.

  5. Survival rate [ Time Frame: At 1, 7 and 30 days after discharge ]
    Record the survival rate after hospital discharged.


Biospecimen Retention:   Samples With DNA

Creatinine, eGFR: blood was collected preoperatively, 4h postoperatively, and at least 3 days postoperatively in the morning.

TIMP-2,IGPBP-7:Urine samples were collected before and after surgery at 4, 12 and 24 hours



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
60 patients undergoing elective cardiac surgery in the Affiliated Hospital of Xuzhou Medical University.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03798067


Contacts
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Contact: Jin Dong Liu, M.S +86-13951355136 liujindong1818@163.com
Contact: Hui Zhang +8615996938739 504099077@qq.com

Sponsors and Collaborators
Xuzhou Medical University
Investigators
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Study Director: Jin Dong Liu, M.S The Affiliated Hospital of Xuzhou Medical University

Publications of Results:
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Responsible Party: Jin Dong Liu, Principal Investigator, Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT03798067     History of Changes
Other Study ID Numbers: XYFY-2018-0008
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual Participant Data(IPD) will be available when this trial is finished and the article have been published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases