<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/NCT04476134</url>
  </required_header>
  <id_info>
    <org_study_id>WestChinaH-2018-01</org_study_id>
    <nct_id>NCT04476134</nct_id>
  </id_info>
  <brief_title>The Perioperative Risks of Adverse Events After Cardiac Surgery: a Retrospective Study</brief_title>
  <acronym>PRAECS</acronym>
  <official_title>The Perioperative Risks of Adverse Events After Cardiac Surgery: a Retrospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lei Du</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West China Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      Cardiac surgeries under cardiopulmonary bypass (CPB) are a major treatment for heart valve&#xD;
      disease and coronary artery disease, and over 1-1.25 million such procedures are performed&#xD;
      annually worldwide. These procedures are associated with mortality rates of 0.9-4.0% and&#xD;
      morbidity rates up to 45.9%.The analysis of perioperative risk factors for these adverse&#xD;
      events can provide beneficial help for improving the prognosis of patients undergoing cardiac&#xD;
      surgery.Patients undergoing cardiac surgery under CPB at West China Hospital of Sichuan&#xD;
      University between January 1, 2011 and June 30, 2017 and the Second Affiliated Hospital in&#xD;
      the School of Medicine of Zhejiang University between September 1, 2013 and June 30, 2017&#xD;
      will be enrolled,and demographic data, preoperative and intraoperative data, and&#xD;
      postoperative adverse events were collected.Independent perioperative risk factors of death,&#xD;
      organ injury and other adverse events in cardiac surgery patients under CPB were studied by&#xD;
      univariate and multivariate Logistic regression analysis to provide evidence for prevention&#xD;
      and intervention in clinic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Anesthesia management The standard procedures of anesthesia and CPB in the two&#xD;
           institutions were applied as described (49, 50). Briefly, anesthesia was induced with&#xD;
           midazolam, sufentanil, muscle relaxant and/or etomidate, and maintained by continuous&#xD;
           remifentanil infusion and sevoflurane inhalation, combined with intermittent muscle&#xD;
           relaxant and sufentanil intravenous injection.&#xD;
&#xD;
        2. CPB management CPB involved a roll pump, a membrane oxygenator, a filter and connecting&#xD;
           tubes and was primed with colloid solution of 1000 mL and 500 ml crystalline liquid.&#xD;
           During CPB, blood flow was at 2.0-2.4 L/m2/min to maintain mean arterial pressure at&#xD;
           50-80 mmHg. Cold 4:1 blood cardioplegia was used for heart arrest. During CPB,&#xD;
           nasopharyngeal temperature was maintained at 32-340C during these procedures and&#xD;
           moderate hemodilution was used. All patients received an initial heparin dose of 375&#xD;
           U/kg to achieve systemic anticoagulation, and additional heparin was intermittently&#xD;
           injected to maintain activated clotting time longer than 480 s during CPB. After weaning&#xD;
           from CPB, heparin was neutralized with protamine in a 1:1 ratio based on the initial&#xD;
           heparin dose.&#xD;
&#xD;
        3. Data Collection Form (DCF) In order to minimize the role of potential confounders on&#xD;
           adverse outcomes, we will do a systematic search for &quot;risk factor, predictor, adverse&#xD;
           outcome, mortality, morbidity, complications, and cardiac surgery&quot; using EMBASE,&#xD;
           Cochrane and PubMed databases from Jan 1, 2000 to Dec 31, 2015. All the perioperative&#xD;
           potential risk factors mentioned in these studies will be on the DCF.&#xD;
&#xD;
        4. Data collection All variables in the DCF will be retrieved from the Hospital Electronic&#xD;
           Medical Record System and medical records. If information on a certain variable cannot&#xD;
           be acquired, it will be recorded as ☒. For example, there may be no record of the&#xD;
           hemoglobin level on the fifth day after surgery, so we will write ☒ in brackets on the&#xD;
           fifth day hemoglobin value.&#xD;
&#xD;
           After the data collection is finished, the investigators will sign their names on the&#xD;
           first page of the DCF.&#xD;
&#xD;
        5. Data Checking Two supervisors will check data promptly. If data are doubted, they will&#xD;
           send their questions to the first investigator. According to the Schedule of Events, an&#xD;
           &quot;X&quot; will be recorded after the data are confirmed to be correct. Once the whole DCF is&#xD;
           completed, the supervisors sign their names and send the DCF to the statisticians.&#xD;
&#xD;
        6. Data Input Data will be input by one statistician using EpiDate3.0 (Odense, Denmark,&#xD;
           http://www.epidata.dk/), and another independent statistician will confirm this&#xD;
           procedure. Then the CRFs will be stored sequentially.&#xD;
&#xD;
        7. Quality control and quality assurance Diagnosis must be performed strictly according to&#xD;
           pre-established definitions. All data in the DCF will be inspected promptly and&#xD;
           correctly in order to guarantee reliability. All procedures in this study will be&#xD;
           performed by two independent researchers.&#xD;
&#xD;
        8. Statistical analysis Data analysis will be carried out by experienced&#xD;
           biostatisticians.Categorical variables are expressed as frequencies (percentages), and&#xD;
           compared between patient groups using the chi-squared or Fisher's exact tests.&#xD;
           Shapiro-Wilk tests are used to determine the distribution of continuous variables.&#xD;
           Normally distributed data are reported as mean ± standard deviation (SD), and compared&#xD;
           between groups using one-way ANOVA test. Skewed data are expressed as median&#xD;
           [interquartile range (IQR)] and compared between groups using Wilcoxon rank sum tests.&#xD;
           The incidence of complications between groups will be performed with the chi-squared&#xD;
           test or Fisher's exact tests. Logistic regression analysis will be performed to evaluate&#xD;
           risk factors for complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Anticipated">October 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>death</measure>
    <time_frame>up to 30 days</time_frame>
    <description>all-cause death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>postoperative complications</measure>
    <time_frame>up to 30 days</time_frame>
    <description>complications after the cardiac surgery</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Risks of Adverse Events After Cardiac Surgery</condition>
  <arm_group>
    <arm_group_label>patients with adverse events</arm_group_label>
    <description>patients underwent adverse events after cardiac surgery</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing cardiac surgery under CPB at West China Hospital of Sichuan University&#xD;
        between January 1, 2011 and June 30, 2017 and the Second Affiliated Hospital in the School&#xD;
        of Medicine of Zhejiang University between September 1, 2013 and June 30, 2017 will be&#xD;
        enrolled, because those hospitals launched electronic medical record systems on January 1,&#xD;
        2011 and September 1, 2013, respectively.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years&#xD;
&#xD;
          2. Valve replacement or/and coronary artery bypass graft surgery under CPB&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Combined surgery involving ascending aortic replacement surgery or cardiac tumor&#xD;
             resection&#xD;
&#xD;
          2. Emergency surgery (defined as surgery performed before the end of the same workday as&#xD;
             admission);&#xD;
&#xD;
          3. Died on the operating table, or could not be weaned off CPB;&#xD;
&#xD;
          4. Medical data missing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lei Du, M.D</last_name>
    <phone>18980601926</phone>
    <email>dulei@scu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>West China Hospital of Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weimin Li, M.D</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Dixon B, Santamaria JD, Reid D, Collins M, Rechnitzer T, Newcomb AE, Nixon I, Yii M, Rosalion A, Campbell DJ. The association of blood transfusion with mortality after cardiac surgery: cause or confounding? (CME). Transfusion. 2013 Jan;53(1):19-27. doi: 10.1111/j.1537-2995.2012.03697.x. Epub 2012 May 11.</citation>
    <PMID>22574710</PMID>
  </results_reference>
  <results_reference>
    <citation>Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.</citation>
    <PMID>22998715</PMID>
  </results_reference>
  <results_reference>
    <citation>Ghali WA, Ash AS, Hall RE, Moskowitz MA. Statewide quality improvement initiatives and mortality after cardiac surgery. JAMA. 1997 Feb 5;277(5):379-82.</citation>
    <PMID>9010169</PMID>
  </results_reference>
  <results_reference>
    <citation>Bridgewater B. Almanac 2012 adult cardiac surgery: the National Society Journals present selected research that has driven recent advances in clinical cardiology. Hellenic J Cardiol. 2013 Jan-Feb;54(1):5-14.</citation>
    <PMID>23340123</PMID>
  </results_reference>
  <results_reference>
    <citation>Raiten JM, Ghadimi K, Augoustides JG, Ramakrishna H, Patel PA, Weiss SJ, Gutsche JT. Atrial fibrillation after cardiac surgery: clinical update on mechanisms and prophylactic strategies. J Cardiothorac Vasc Anesth. 2015;29(3):806-16. doi: 10.1053/j.jvca.2015.01.001. No abstract available.</citation>
    <PMID>26009291</PMID>
  </results_reference>
  <results_reference>
    <citation>Maganti MD, Rao V, Borger MA, Ivanov J, David TE. Predictors of low cardiac output syndrome after isolated aortic valve surgery. Circulation. 2005 Aug 30;112(9 Suppl):I448-52. doi: 10.1161/CIRCULATIONAHA.104.526087.</citation>
    <PMID>16159861</PMID>
  </results_reference>
  <results_reference>
    <citation>Kuitunen A, Vento A, Suojaranta-Ylinen R, Pettila V. Acute renal failure after cardiac surgery: evaluation of the RIFLE classification. Ann Thorac Surg. 2006 Feb;81(2):542-6. doi: 10.1016/j.athoracsur.2005.07.047.</citation>
    <PMID>16427848</PMID>
  </results_reference>
  <results_reference>
    <citation>Haase M, Bellomo R, Matalanis G, Calzavacca P, Dragun D, Haase-Fielitz A. A comparison of the RIFLE and Acute Kidney Injury Network classifications for cardiac surgery-associated acute kidney injury: a prospective cohort study. J Thorac Cardiovasc Surg. 2009 Dec;138(6):1370-6. doi: 10.1016/j.jtcvs.2009.07.007. Epub 2009 Sep 5.</citation>
    <PMID>19733864</PMID>
  </results_reference>
  <results_reference>
    <citation>McDonagh DL, Berger M, Mathew JP, Graffagnino C, Milano CA, Newman MF. Neurological complications of cardiac surgery. Lancet Neurol. 2014 May;13(5):490-502. doi: 10.1016/S1474-4422(14)70004-3. Epub 2014 Apr 2.</citation>
    <PMID>24703207</PMID>
  </results_reference>
  <results_reference>
    <citation>Lomivorotov VV, Efremov SM, Kirov MY, Fominskiy EV, Karaskov AM. Low-Cardiac-Output Syndrome After Cardiac Surgery. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):291-308. doi: 10.1053/j.jvca.2016.05.029. Epub 2016 Jul 29. No abstract available.</citation>
    <PMID>27671216</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>West China Hospital</investigator_affiliation>
    <investigator_full_name>Lei Du</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Because this research is ongoing,and individual participant data involve privacy of patients,we have not decided whether sharing data with other researchers.</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/NCT04476134
org study id: WestChinaH-2018-01
nct id: NCT04476134
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiac surgeries under cardiopulmonary bypass (CPB) are a major treatment for heart valve
      disease and coronary artery disease, and over 1-1.25 million such procedures are performed
      annually worldwide. These procedures are associated with mortality rates of 0.9-4.0% and
      morbidity rates up to 45.9%.The analysis of perioperative risk factors for these adverse
      events can provide beneficial help for improving the prognosis of patients undergoing cardiac
      surgery.Patients undergoing cardiac surgery under CPB at West China Hospital of Sichuan
      University between January 1, 2011 and June 30, 2017 and the Second Affiliated Hospital in
      the School of Medicine of Zhejiang University between September 1, 2013 and June 30, 2017
      will be enrolled,and demographic data, preoperative and intraoperative data, and
      postoperative adverse events were collected.Independent perioperative risk factors of death,
      organ injury and other adverse events in cardiac surgery patients under CPB were studied by
      univariate and multivariate Logistic regression analysis to provide evidence for prevention
      and intervention in clinic.
1. Anesthesia management The standard procedures of anesthesia and CPB in the two
           institutions were applied as described (49, 50). Briefly, anesthesia was induced with
           midazolam, sufentanil, muscle relaxant and/or etomidate, and maintained by continuous
           remifentanil infusion and sevoflurane inhalation, combined with intermittent muscle
           relaxant and sufentanil intravenous injection.

        2. CPB management CPB involved a roll pump, a membrane oxygenator, a filter and connecting
           tubes and was primed with colloid solution of 1000 mL and 500 ml crystalline liquid.
           During CPB, blood flow was at 2.0-2.4 L/m2/min to maintain mean arterial pressure at
           50-80 mmHg. Cold 4:1 blood cardioplegia was used for heart arrest. During CPB,
           nasopharyngeal temperature was maintained at 32-340C during these procedures and
           moderate hemodilution was used. All patients received an initial heparin dose of 375
           U/kg to achieve systemic anticoagulation, and additional heparin was intermittently
           injected to maintain activated clotting time longer than 480 s during CPB. After weaning
           from CPB, heparin was neutralized with protamine in a 1:1 ratio based on the initial
           heparin dose.

        3. Data Collection Form (DCF) In order to minimize the role of potential confounders on
           adverse outcomes, we will do a systematic search for "risk factor, predictor, adverse
           outcome, mortality, morbidity, complications, and cardiac surgery" using EMBASE,
           Cochrane and PubMed databases from Jan 1, 2000 to Dec 31, 2015. All the perioperative
           potential risk factors mentioned in these studies will be on the DCF.

        4. Data collection All variables in the DCF will be retrieved from the Hospital Electronic
           Medical Record System and medical records. If information on a certain variable cannot
           be acquired, it will be recorded as ☒. For example, there may be no record of the
           hemoglobin level on the fifth day after surgery, so we will write ☒ in brackets on the
           fifth day hemoglobin value.

           After the data collection is finished, the investigators will sign their names on the
           first page of the DCF.

        5. Data Checking Two supervisors will check data promptly. If data are doubted, they will
           send their questions to the first investigator. According to the Schedule of Events, an
           "X" will be recorded after the data are confirmed to be correct. Once the whole DCF is
           completed, the supervisors sign their names and send the DCF to the statisticians.

        6. Data Input Data will be input by one statistician using EpiDate3.0 (Odense, Denmark,
           http://www.epidata.dk/), and another independent statistician will confirm this
           procedure. Then the CRFs will be stored sequentially.

        7. Quality control and quality assurance Diagnosis must be performed strictly according to
           pre-established definitions. All data in the DCF will be inspected promptly and
           correctly in order to guarantee reliability. All procedures in this study will be
           performed by two independent researchers.

        8. Statistical analysis Data analysis will be carried out by experienced
           biostatisticians.Categorical variables are expressed as frequencies (percentages), and
           compared between patient groups using the chi-squared or Fisher's exact tests.
           Shapiro-Wilk tests are used to determine the distribution of continuous variables.
           Normally distributed data are reported as mean ± standard deviation (SD), and compared
           between groups using one-way ANOVA test. Skewed data are expressed as median
           [interquartile range (IQR)] and compared between groups using Wilcoxon rank sum tests.
           The incidence of complications between groups will be performed with the chi-squared
           test or Fisher's exact tests. Logistic regression analysis will be performed to evaluate
           risk factors for complications.
observational model: Case-Control
time perspective: Retrospective
measure: death
time frame: up to 30 days
description: all-cause death
measure: postoperative complications
time frame: up to 30 days
description: complications after the cardiac surgery
arm group label: patients with adverse events
description: patients underwent adverse events after cardiac surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lei Du, M.D
phone: 18980601926
email: dulei@scu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
citation: Dixon B, Santamaria JD, Reid D, Collins M, Rechnitzer T, Newcomb AE, Nixon I, Yii M, Rosalion A, Campbell DJ. The association of blood transfusion with mortality after cardiac surgery: cause or confounding? (CME). Transfusion. 2013 Jan;53(1):19-27. doi: 10.1111/j.1537-2995.2012.03697.x. Epub 2012 May 11.
PMID: 22574710
citation: Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.
PMID: 22998715
citation: Ghali WA, Ash AS, Hall RE, Moskowitz MA. Statewide quality improvement initiatives and mortality after cardiac surgery. JAMA. 1997 Feb 5;277(5):379-82.
PMID: 9010169
citation: Bridgewater B. Almanac 2012 adult cardiac surgery: the National Society Journals present selected research that has driven recent advances in clinical cardiology. Hellenic J Cardiol. 2013 Jan-Feb;54(1):5-14.
PMID: 23340123
citation: Raiten JM, Ghadimi K, Augoustides JG, Ramakrishna H, Patel PA, Weiss SJ, Gutsche JT. Atrial fibrillation after cardiac surgery: clinical update on mechanisms and prophylactic strategies. J Cardiothorac Vasc Anesth. 2015;29(3):806-16. doi: 10.1053/j.jvca.2015.01.001. No abstract available.
PMID: 26009291
citation: Maganti MD, Rao V, Borger MA, Ivanov J, David TE. Predictors of low cardiac output syndrome after isolated aortic valve surgery. Circulation. 2005 Aug 30;112(9 Suppl):I448-52. doi: 10.1161/CIRCULATIONAHA.104.526087.
PMID: 16159861
citation: Kuitunen A, Vento A, Suojaranta-Ylinen R, Pettila V. Acute renal failure after cardiac surgery: evaluation of the RIFLE classification. Ann Thorac Surg. 2006 Feb;81(2):542-6. doi: 10.1016/j.athoracsur.2005.07.047.
PMID: 16427848
citation: Haase M, Bellomo R, Matalanis G, Calzavacca P, Dragun D, Haase-Fielitz A. A comparison of the RIFLE and Acute Kidney Injury Network classifications for cardiac surgery-associated acute kidney injury: a prospective cohort study. J Thorac Cardiovasc Surg. 2009 Dec;138(6):1370-6. doi: 10.1016/j.jtcvs.2009.07.007. Epub 2009 Sep 5.
PMID: 19733864
citation: McDonagh DL, Berger M, Mathew JP, Graffagnino C, Milano CA, Newman MF. Neurological complications of cardiac surgery. Lancet Neurol. 2014 May;13(5):490-502. doi: 10.1016/S1474-4422(14)70004-3. Epub 2014 Apr 2.
PMID: 24703207
citation: Lomivorotov VV, Efremov SM, Kirov MY, Fominskiy EV, Karaskov AM. Low-Cardiac-Output Syndrome After Cardiac Surgery. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):291-308. doi: 10.1053/j.jvca.2016.05.029. Epub 2016 Jul 29. No abstract available.
PMID: 27671216
responsible party type: Sponsor-Investigator
investigator affiliation: West China Hospital
investigator full name: Lei Du
investigator title: professor
sharing ipd: Undecided
ipd description: Because this research is ongoing,and individual participant data involve privacy of patients,we have not decided whether sharing data with other researchers.