<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/NCT03789747</url>
  </required_header>
  <id_info>
    <org_study_id>Beijing Tiantan Hospital</org_study_id>
    <nct_id>NCT03789747</nct_id>
  </id_info>
  <brief_title>Acute Kidney Injury After Craniocerebral Operation</brief_title>
  <official_title>Incidence and Risk Factors of Acute Kidney Injury After Craniocerebral Operation: A Single-Center Experience</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Tiantan Hospital</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>
      The aim of this study was to report the incidence, severity and risk factors of acute kidney&#xD;
      injury (AKI) in patients underwent craniocerebral operation and admitted into intensive care&#xD;
      unit (ICU).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study included consecutive adult patients who underwent craniotomy and admitted into&#xD;
      intensive care unit (ICU) between January 2017 and December 2018. Patients with congenital&#xD;
      renal abnormalities or with stages 4 and 5 chronic kidney disease (CKD) were excluded. Serum&#xD;
      creatinine levels were measured before operation, daily after operation until discharged from&#xD;
      ICU ward . AKI was depicted according to changes in early postoperative serum creatinine&#xD;
      levels and its severity was determined based on the Acute Kidney Injury Network (AKIN)&#xD;
      classification. Univariate and multivariate statistical analyses were conducted to determine&#xD;
      risk factors for developing AKI.&#xD;
&#xD;
      Preoperative, intraoperative and postoperative variables known to be or could potentially be&#xD;
      associated with AKI or other adverse outcomes were collected. Preoperation variables include&#xD;
      age, gender, weight, hypertension, diabetes mellitus, hyperuricemia, proteinuria,&#xD;
      preoperative serum Cr and estimated estimated glomerular filtration rate (eGFR), left&#xD;
      ventricular ejection fraction (LVEF), Charlson Comorbidity Index (CCI), emergency surgery and&#xD;
      intravenous contrast. eGFR was calculated with MDRD4 equation. Proteinuria was defined as&#xD;
      protein &gt; 15 mg/dl in spot urine specimens. Hyperuricemia was defined as a serum uric acid &gt;&#xD;
      6.6 in women and &gt; 7.0 mg/dl in men. Patients were considered to have diabetes if they were&#xD;
      diagnosed with type 1 or type 2 diabetes mellitus before or were taking insulin or oral&#xD;
      hypoglycemic agents at the time of cardiac surgery. Hypertension was defined as SBP &gt; 140 mm&#xD;
      Hg and/or DBP &gt; 90 mm Hg; or had hypertension history and were taking antihypertensive drugs.&#xD;
      LVEF was assessed preoperatively by echocardiography. Charlson Comorbidity Index was used to&#xD;
      measure comorbid disease status by calculating the comorbidity score.&#xD;
&#xD;
      Intra-operative variables include surgery type, duration of operation, blood transfusion,&#xD;
      urine output,the highest and lowest mean blood pressures, use of radiocontrast agents and&#xD;
      dehydrants.&#xD;
&#xD;
      Postoperation variables include hypotension, central venous pressure (CVP), oliguria,&#xD;
      re-exploration, mechanical ventilation, use of angiotensin-converting enzyme&#xD;
      inhibitor/angiotensin receptor blocker (ACEI/ARB), radiocontrast agents, dehydrants and RRT.&#xD;
      Hypotension was defined as SBP &lt; 90 mm Hg postoperative but before the diagnosis of AKI.&#xD;
&#xD;
      Patients were followed until discharge and all-cause in-hospital mortality was recorded. The&#xD;
      length of stay in the ICU and hospital was also recorded. The mortality rates of the patients&#xD;
      with or without AKI were compared.&#xD;
&#xD;
      Continuous variables were expressed as mean (SD) and analyzed by unpaired Student's t test.&#xD;
      Nonparametric variables were expressed as median and 25-75% percentiles and analyzed by the&#xD;
      Mann-Whitney test. Categorical variables were expressed as absolute (n) and relative (%)&#xD;
      frequency and were analyzed by chi-square test, as appropriate. A multivariate logistic&#xD;
      regression model incorporating all factors associated with AKI in univariate analysis as well&#xD;
      as those factors showing a univariate p value &lt; 0.05 was performed to identify associated&#xD;
      risk factors with AKI, while Cox Proportional Hazards model was used to identify associated&#xD;
      factors with in-hospital mortality and hazard ratios. Risk data are presented as odds or&#xD;
      hazard ratios with 95% CIs. p &lt; 0.05 was considered statistically significant for all&#xD;
      comparisons. SPSS version 19.0 for windows software was used for the statistical analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>Incidence and outcome of AKI after Craniotomy</measure>
    <time_frame>1 month</time_frame>
    <description>All adult patients who underwent craniotomy and admitted into intensive care unit (ICU) between January 2017 and December 2018 were screened for acute kidney injury.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk factors for AKI after Craniotomy</measure>
    <time_frame>1 month</time_frame>
    <description>Preoperative, intraoperative and postoperative variables known to be or could potentially be associated with AKI or other adverse outcomes were collected. A multivariate logistic regression model incorporating all factors associated with AKI in univariate analysis as well as those factors showing a univariate p value &lt; 0.05 was performed to identify associated risk factors with AKI.</description>
  </secondary_outcome>
  <enrollment type="Actual">143</enrollment>
  <condition>Epidemiology</condition>
  <condition>Acute Kidney Injury</condition>
  <condition>Risk Factor</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>As a observational study, there is no intervention.</intervention_name>
    <description>As a observational study, there is no intervention.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients who underwent craniocerebral operation and admitted into intensive care unit&#xD;
        (ICU) between January 2017 and December 2018 were consecutively screened . Patients&#xD;
        developed AKI during their ICU admissions were deemed as cases, and those without AKI were&#xD;
        included in the control group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients underwent craniocerebral surgery;&#xD;
&#xD;
          -  admitted into ICU ward.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age&lt; 18 years;&#xD;
&#xD;
          -  Patients with congenital renal abnormities or with stages 4 and 5 chronic kidney&#xD;
             disease (CKD).&#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_official>
    <last_name>Jianxin Zhou, MD</last_name>
    <role>Study Director</role>
    <affiliation>Beijing Tian Tan Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guangzhi Shi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Beijing Tian Tan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Tian Tan hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 11, 2017</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Tiantan Hospital</investigator_affiliation>
    <investigator_full_name>Jianfang Zhou</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>incidence</keyword>
  <keyword>outcome</keyword>
  <keyword>acute kidney injury</keyword>
  <keyword>risk factor</keyword>
  <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>No</sharing_ipd>
  </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/NCT03789747
org study id: Beijing Tiantan Hospital
nct id: NCT03789747
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to report the incidence, severity and risk factors of acute kidney
      injury (AKI) in patients underwent craniocerebral operation and admitted into intensive care
      unit (ICU).
The study included consecutive adult patients who underwent craniotomy and admitted into
      intensive care unit (ICU) between January 2017 and December 2018. Patients with congenital
      renal abnormalities or with stages 4 and 5 chronic kidney disease (CKD) were excluded. Serum
      creatinine levels were measured before operation, daily after operation until discharged from
      ICU ward . AKI was depicted according to changes in early postoperative serum creatinine
      levels and its severity was determined based on the Acute Kidney Injury Network (AKIN)
      classification. Univariate and multivariate statistical analyses were conducted to determine
      risk factors for developing AKI.

      Preoperative, intraoperative and postoperative variables known to be or could potentially be
      associated with AKI or other adverse outcomes were collected. Preoperation variables include
      age, gender, weight, hypertension, diabetes mellitus, hyperuricemia, proteinuria,
      preoperative serum Cr and estimated estimated glomerular filtration rate (eGFR), left
      ventricular ejection fraction (LVEF), Charlson Comorbidity Index (CCI), emergency surgery and
      intravenous contrast. eGFR was calculated with MDRD4 equation. Proteinuria was defined as
      protein > 15 mg/dl in spot urine specimens. Hyperuricemia was defined as a serum uric acid >
      6.6 in women and > 7.0 mg/dl in men. Patients were considered to have diabetes if they were
      diagnosed with type 1 or type 2 diabetes mellitus before or were taking insulin or oral
      hypoglycemic agents at the time of cardiac surgery. Hypertension was defined as SBP > 140 mm
      Hg and/or DBP > 90 mm Hg; or had hypertension history and were taking antihypertensive drugs.
      LVEF was assessed preoperatively by echocardiography. Charlson Comorbidity Index was used to
      measure comorbid disease status by calculating the comorbidity score.

      Intra-operative variables include surgery type, duration of operation, blood transfusion,
      urine output,the highest and lowest mean blood pressures, use of radiocontrast agents and
      dehydrants.

      Postoperation variables include hypotension, central venous pressure (CVP), oliguria,
      re-exploration, mechanical ventilation, use of angiotensin-converting enzyme
      inhibitor/angiotensin receptor blocker (ACEI/ARB), radiocontrast agents, dehydrants and RRT.
      Hypotension was defined as SBP < 90 mm Hg postoperative but before the diagnosis of AKI.

      Patients were followed until discharge and all-cause in-hospital mortality was recorded. The
      length of stay in the ICU and hospital was also recorded. The mortality rates of the patients
      with or without AKI were compared.

      Continuous variables were expressed as mean (SD) and analyzed by unpaired Student's t test.
      Nonparametric variables were expressed as median and 25-75% percentiles and analyzed by the
      Mann-Whitney test. Categorical variables were expressed as absolute (n) and relative (%)
      frequency and were analyzed by chi-square test, as appropriate. A multivariate logistic
      regression model incorporating all factors associated with AKI in univariate analysis as well
      as those factors showing a univariate p value < 0.05 was performed to identify associated
      risk factors with AKI, while Cox Proportional Hazards model was used to identify associated
      factors with in-hospital mortality and hazard ratios. Risk data are presented as odds or
      hazard ratios with 95% CIs. p < 0.05 was considered statistically significant for all
      comparisons. SPSS version 19.0 for windows software was used for the statistical analysis.
observational model: Cohort
time perspective: Prospective
measure: Incidence and outcome of AKI after Craniotomy
time frame: 1 month
description: All adult patients who underwent craniotomy and admitted into intensive care unit (ICU) between January 2017 and December 2018 were screened for acute kidney injury.
measure: Risk factors for AKI after Craniotomy
time frame: 1 month
description: Preoperative, intraoperative and postoperative variables known to be or could potentially be associated with AKI or other adverse outcomes were collected. A multivariate logistic regression model incorporating all factors associated with AKI in univariate analysis as well as those factors showing a univariate p value < 0.05 was performed to identify associated risk factors with AKI.
intervention type: Other
intervention name: As a observational study, there is no intervention.
description: As a observational study, there is no intervention.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jianxin Zhou, MD
role: Study Director
affiliation: Beijing Tian Tan Hospital
last name: Guangzhi Shi, MD
role: Study Director
affiliation: Beijing Tian Tan Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Tiantan Hospital
investigator full name: Jianfang Zhou
investigator title: Principal investigator
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries
sharing ipd: No