<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03798067</url>
  </required_header>
  <id_info>
    <org_study_id>XYFY-2018-0008</org_study_id>
    <nct_id>NCT03798067</nct_id>
  </id_info>
  <brief_title>Correlation Between Monitoring Renal Hemodynamics by Esophageal Ultrasound and Acute Kidney Injury After Heart Surgery</brief_title>
  <official_title>Correlation Between Monitoring Renal Hemodynamics by Esophageal Ultrasound and Acute Kidney Injury After Heart Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xuzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xuzhou Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute kidney injury (AKI) is a common complication of cardiac surgery, which seriously&#xD;
      affects the postoperative complication rate and mortality of patients.Acute kidney injury&#xD;
      occurs in 5-30% of patients after cardiac surgery, but severe acute kidney injury requiring&#xD;
      dialysis is relatively rare.At present, the diagnosis of AKI is based on serum creatinine&#xD;
      (Scr) or urine volume. However, the changes of serum creatinine value have hysteresis, and&#xD;
      the increase of serum creatinine level lags behind kidney injury for 48 ~ 72 h.Some drugs can&#xD;
      also affect creatinine levels.Urine volume is also affected by many factors.Due to the lack&#xD;
      of sensitivity and specificity of SCr, it is very important to find and adopt new early AKI&#xD;
      markers.Kidney is an important metabolic organ of human body. Different from cerebrovascular&#xD;
      system, kidney lacks automatic regulation ability and is easily affected by perfusion&#xD;
      flow.Previous experiments have shown that placing a multi-plane esophageal probe into the&#xD;
      human stomach through the esophagus can monitor the changes of left renal blood flow before,&#xD;
      during and after cardiovascular surgery extracorporeal circulation, and has good&#xD;
      repeatability, which may become an effective means to monitor renal blood flow during&#xD;
      cardiovascular surgery.&#xD;
&#xD;
      In conclusion, this study intends to use esophageal ultrasound as a means to monitor renal&#xD;
      blood flow, observe the changes of intraoperative renal hemodynamic indexes, and use KDIGO (&#xD;
      Kidney Disease:Improving Global Outcomes)as the standard of renal injury to explore the&#xD;
      correlation between intraoperative hemodynamic changes and postoperative AKI, providing a new&#xD;
      perspective for the pathophysiological study of AKI after cardiopulmonary bypass.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The mechanism of acute kidney injury after CPB has not been fully elucidated, and current&#xD;
      studies suggest that the main mechanisms are as follows:&#xD;
&#xD;
      (1) endogenous/exogenous nephrotoxic substances;(2) metabolic factors: mainly reflected in&#xD;
      the preoperative status of patients, such as obesity, low body weight, etc.;(3) hemodynamic&#xD;
      factors: hemodynamic instability is an important mechanism for further renal injury process&#xD;
      such as ischemia reperfusion, which is mainly reflected in: a.preoperative and postoperative&#xD;
      hypotension: cardiogenic shock caused by cardiac insufficiency and low cardiac&#xD;
      displacement;Non-cardiogenic shock (vasoactive drugs/allergies/postoperative bleeding);b.&#xD;
      hemodynamic instability of intraoperative intervention: deep anesthesia, intraoperative blood&#xD;
      loss, CPB-related intraoperative low perfusion (long CPB time, low circulation flow, low mean&#xD;
      arterial pressure in CPB), embolic release (atherosclerotic emboli/air emboli), aorta and&#xD;
      distal arteriotomy;(4) neurohumoral system factors: hormones such as epinephrine,&#xD;
      norepinephrine, renin and thyroxine change to varying degrees during cardiac surgery and CPB,&#xD;
      thus affecting the body state and systemic blood vessels;(5) inflammation and oxidative&#xD;
      stress.&#xD;
&#xD;
      Kidney is an important metabolic organ of human body. Different from cerebrovascular system,&#xD;
      kidney lacks automatic regulation ability and is easily affected by perfusion flow.For&#xD;
      patients at high risk of postoperative acute kidney injury, appropriate intraoperative&#xD;
      perfusion may reduce the incidence of postoperative acute kidney injury.&#xD;
&#xD;
      Esophageal ultrasound was used as a means of monitoring renal blood flow to observe the&#xD;
      changes in intraoperative renal hemodynamic indexes. Meanwhile, KDIGO was used as the&#xD;
      standard for renal injury. AKI was divided into two groups according to whether postoperative&#xD;
      AKI occurred, and the correlation between intraoperative hemodynamic changes and&#xD;
      postoperative AKI in the two groups was discussed.It provides new ideas for the early&#xD;
      diagnosis of postoperative acute kidney injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>AUC(RI)</measure>
    <time_frame>RI monitored 30 minutes after cardiopulmonary bypass termination</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(PI)</measure>
    <time_frame>PI monitored 30 minutes after cardiopulmonary bypass termination</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in biomarkers</measure>
    <time_frame>Before surgery and at 4 hours, 12 hours, and 24 hours after surgery</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay</measure>
    <time_frame>an average of 2 days</time_frame>
    <description>All patients are routinely transferred to ICU after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>an average of 10 days</time_frame>
    <description>All patients are routinely transferred to ICU after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of renal replacement therapy</measure>
    <time_frame>Until 3 months after discharge</time_frame>
    <description>The use of postoperative renal replacement therapy depends on the diagnosis and treatment of ICU staff.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival rate</measure>
    <time_frame>At 1, 7 and 30 days after discharge</time_frame>
    <description>Record the survival rate after hospital discharged.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Postoperative Acute Kidney Injury</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Creatinine, eGFR: blood was collected preoperatively, 4h postoperatively, and at least 3 days&#xD;
      postoperatively in the morning.&#xD;
&#xD;
      TIMP-2,IGPBP-7:Urine samples were collected before and after surgery at 4, 12 and 24 hours&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        60 patients undergoing elective cardiac surgery in the Affiliated Hospital of Xuzhou&#xD;
        Medical University.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 18 and 70;&#xD;
&#xD;
          -  Elective cardiopulmonary bypass for patients undergoing cardiac surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute myocardial infarction surgery within 7 days&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Known renal artery stenosis, renal malformation;Renal failure&#xD;
&#xD;
          -  Congenital esophageal malformation&#xD;
&#xD;
          -  Patients with previous history of stomach and esophagus should avoid intraoperative&#xD;
             esophageal ultrasound examination&#xD;
&#xD;
          -  Existing acute kidney injury, kidney transplantation, chronic kidney disease and&#xD;
             glomerular filtration rate less than 30 ml/min,&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin Dong Liu, M.S</last_name>
    <role>Study Director</role>
    <affiliation>The Affiliated Hospital of Xuzhou Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jin Dong Liu, M.S</last_name>
    <phone>+86-13951355136</phone>
    <email>liujindong1818@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hui Zhang</last_name>
    <phone>+8615996938739</phone>
    <email>504099077@qq.com</email>
  </overall_contact_backup>
  <results_reference>
    <citation>Weisse AB. Cardiac surgery: a century of progress. Tex Heart Inst J. 2011;38(5):486-90.</citation>
    <PMID>22163121</PMID>
  </results_reference>
  <results_reference>
    <citation>Wang Y, Bellomo R. Cardiac surgery-associated acute kidney injury: risk factors, pathophysiology and treatment. Nat Rev Nephrol. 2017 Nov;13(11):697-711. doi: 10.1038/nrneph.2017.119. Epub 2017 Sep 4.</citation>
    <PMID>28869251</PMID>
  </results_reference>
  <results_reference>
    <citation>Bellos I, Pergialiotis V, Kontzoglou K. Renal resistive index as predictor of acute kidney injury after major surgery: A systematic review and meta-analysis. J Crit Care. 2019 Apr;50:36-43. doi: 10.1016/j.jcrc.2018.11.001. Epub 2018 Nov 15.</citation>
    <PMID>30471559</PMID>
  </results_reference>
  <results_reference>
    <citation>Regolisti G, Maggiore U, Cademartiri C, Belli L, Gherli T, Cabassi A, Morabito S, Castellano G, Gesualdo L, Fiaccadori E. Renal resistive index by transesophageal and transparietal echo-doppler imaging for the prediction of acute kidney injury in patients undergoing major heart surgery. J Nephrol. 2017 Apr;30(2):243-253. doi: 10.1007/s40620-016-0289-2. Epub 2016 Mar 19.</citation>
    <PMID>26995003</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 4, 2019</last_update_submitted>
  <last_update_submitted_qc>January 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xuzhou Medical University</investigator_affiliation>
    <investigator_full_name>Jin Dong Liu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Individual Participant Data(IPD) will be available when this trial is finished and the article have been published.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03798067
org study id: XYFY-2018-0008
nct id: NCT03798067
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: AUC(RI)
time frame: RI monitored 30 minutes after cardiopulmonary bypass termination
description: 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.
measure: AUC(PI)
time frame: PI monitored 30 minutes after cardiopulmonary bypass termination
description: 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.
measure: Changes in biomarkers
time frame: Before surgery and at 4 hours, 12 hours, and 24 hours after surgery
description: 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).
measure: Length of ICU stay
time frame: an average of 2 days
description: All patients are routinely transferred to ICU after surgery
measure: Length of hospital stay
time frame: an average of 10 days
description: All patients are routinely transferred to ICU after surgery
measure: Use of renal replacement therapy
time frame: Until 3 months after discharge
description: The use of postoperative renal replacement therapy depends on the diagnosis and treatment of ICU staff.
measure: Survival rate
time frame: At 1, 7 and 30 days after discharge
description: Record the survival rate after hospital discharged.
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
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jin Dong Liu, M.S
role: Study Director
affiliation: The Affiliated Hospital of Xuzhou Medical University
last name: Jin Dong Liu, M.S
phone: +86-13951355136
email: liujindong1818@163.com
last name: Hui Zhang
phone: +8615996938739
email: 504099077@qq.com
citation: Weisse AB. Cardiac surgery: a century of progress. Tex Heart Inst J. 2011;38(5):486-90.
PMID: 22163121
citation: Wang Y, Bellomo R. Cardiac surgery-associated acute kidney injury: risk factors, pathophysiology and treatment. Nat Rev Nephrol. 2017 Nov;13(11):697-711. doi: 10.1038/nrneph.2017.119. Epub 2017 Sep 4.
PMID: 28869251
citation: Bellos I, Pergialiotis V, Kontzoglou K. Renal resistive index as predictor of acute kidney injury after major surgery: A systematic review and meta-analysis. J Crit Care. 2019 Apr;50:36-43. doi: 10.1016/j.jcrc.2018.11.001. Epub 2018 Nov 15.
PMID: 30471559
citation: Regolisti G, Maggiore U, Cademartiri C, Belli L, Gherli T, Cabassi A, Morabito S, Castellano G, Gesualdo L, Fiaccadori E. Renal resistive index by transesophageal and transparietal echo-doppler imaging for the prediction of acute kidney injury in patients undergoing major heart surgery. J Nephrol. 2017 Apr;30(2):243-253. doi: 10.1007/s40620-016-0289-2. Epub 2016 Mar 19.
PMID: 26995003
responsible party type: Principal Investigator
investigator affiliation: Xuzhou Medical University
investigator full name: Jin Dong Liu
investigator title: Principal Investigator
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries
sharing ipd: Undecided
ipd description: Individual Participant Data(IPD) will be available when this trial is finished and the article have been published.