<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/NCT03806413</url>
  </required_header>
  <id_info>
    <org_study_id>16/68(8/2/2017)</org_study_id>
    <nct_id>NCT03806413</nct_id>
  </id_info>
  <brief_title>Post-surgical Delirium in Patients Undergoing Open Heart Surgery.</brief_title>
  <official_title>Post-surgical Delirium in Patients Undergoing Open Heart Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alexandria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alexandria</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>
      Post-surgical delirium in patients undergoing open heart surgery. Introduction Delirium&#xD;
      occurs after open heart surgery may reach about 1/3 of the patients.(1)&#xD;
&#xD;
      Aim The aim of this study is to determine the incidence of delirium after open heart surgery&#xD;
      and the associated risk factors in Alexandria University hospital.&#xD;
&#xD;
      Patients and Methods The study will be done on patients undergoing open heart surgery in&#xD;
      Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item&#xD;
      Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done&#xD;
      preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done&#xD;
      3, 6 9 and 12 months after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post-surgical delirium in patients undergoing open heart surgery. Introduction Delirium&#xD;
      occurs after open heart surgery may reach about 1/3 of the patients.(1)&#xD;
&#xD;
      Aim The aim of this study is to determine the incidence of delirium after open heart surgery&#xD;
      and the associated risk factors in Alexandria University hospital.&#xD;
&#xD;
      Patients and Methods The study will be done on patients undergoing open heart surgery in&#xD;
      Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item&#xD;
      Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done&#xD;
      preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done&#xD;
      3, 6 9 and 12 months after surgery.&#xD;
&#xD;
      Results Results will be collected in tables and graphs. Appropriate statistical analysis will&#xD;
      be done.&#xD;
&#xD;
      Discussion Results of the study will be discussed compared to other studies.&#xD;
&#xD;
      References&#xD;
&#xD;
      1-Jannati Y, Bagheri-Nesami M, Sohrabi M, Yazdani-Cherati J, Mazdarani S. Factors associated&#xD;
      with post-surgical delirium in patients undergoing open heart surgery. Oman Med J. 2014&#xD;
      Sep;29(5):340-5.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2022</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Post-surgical delirium in patients undergoing open heart surgery.</measure>
    <time_frame>1 year</time_frame>
    <description>Post-surgical delirium in patients undergoing open heart surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>1 year</time_frame>
    <description>Mortality</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Delirium</condition>
  <condition>Open Heart Surgery</condition>
  <arm_group>
    <arm_group_label>Open heart surgery</arm_group_label>
    <description>The study will be done on patients undergoing open heart surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6 9 and 12 months after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Open heart surgery</intervention_name>
    <description>The study will be done on patients undergoing open heart surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6 9 and 12 months after surgery.</description>
    <arm_group_label>Open heart surgery</arm_group_label>
    <other_name>On-pump cardiac surgery</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients undergoing open heart surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:Adult patients undergoing open heart surgery. -&#xD;
&#xD;
        Exclusion Criteria: Children, patient refusal.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohammad Hazem I Ahmad Sabry, MB,ChB MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohammad Hazem Ahmad Sabry, MB,ChB</last_name>
    <phone>01062718827</phone>
    <email>mohammad_hazem@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Alexandria Faculty of Medicine</name>
      <address>
        <city>Alexandria</city>
        <zip>21111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammad Hazem I Ahmad Sabry, MB,ChB MD</last_name>
      <phone>+2034842236</phone>
      <email>mohammad_hazem@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Jannati Y, Bagheri-Nesami M, Sohrabi M, Yazdani-Cherati J, Mazdarani S. Factors associated with post-surgical delirium in patients undergoing open heart surgery. Oman Med J. 2014 Sep;29(5):340-5. doi: 10.5001/omj.2014.91.</citation>
    <PMID>25337310</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 5, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>September 25, 2021</last_update_submitted>
  <last_update_submitted_qc>September 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alexandria</investigator_affiliation>
    <investigator_full_name>Mohammad Hazem I. Ahmad Sabry</investigator_full_name>
    <investigator_title>Lecturer of Anesthesia</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</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/NCT03806413
org study id: 16/68(8/2/2017)
nct id: NCT03806413
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Post-surgical delirium in patients undergoing open heart surgery. Introduction Delirium
      occurs after open heart surgery may reach about 1/3 of the patients.(1)

      Aim The aim of this study is to determine the incidence of delirium after open heart surgery
      and the associated risk factors in Alexandria University hospital.

      Patients and Methods The study will be done on patients undergoing open heart surgery in
      Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item
      Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done
      preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done
      3, 6 9 and 12 months after surgery.
Post-surgical delirium in patients undergoing open heart surgery. Introduction Delirium
      occurs after open heart surgery may reach about 1/3 of the patients.(1)

      Aim The aim of this study is to determine the incidence of delirium after open heart surgery
      and the associated risk factors in Alexandria University hospital.

      Patients and Methods The study will be done on patients undergoing open heart surgery in
      Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item
      Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done
      preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done
      3, 6 9 and 12 months after surgery.

      Results Results will be collected in tables and graphs. Appropriate statistical analysis will
      be done.

      Discussion Results of the study will be discussed compared to other studies.

      References

      1-Jannati Y, Bagheri-Nesami M, Sohrabi M, Yazdani-Cherati J, Mazdarani S. Factors associated
      with post-surgical delirium in patients undergoing open heart surgery. Oman Med J. 2014
      Sep;29(5):340-5.
observational model: Cohort
time perspective: Prospective
measure: Post-surgical delirium in patients undergoing open heart surgery.
time frame: 1 year
description: Post-surgical delirium in patients undergoing open heart surgery.
measure: Mortality
time frame: 1 year
description: Mortality
arm group label: Open heart surgery
description: The study will be done on patients undergoing open heart surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6 9 and 12 months after surgery.
intervention type: Other
intervention name: Open heart surgery
description: The study will be done on patients undergoing open heart surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6 9 and 12 months after surgery.
arm group label: Open heart surgery
other name: On-pump cardiac surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Mohammad Hazem I Ahmad Sabry, MB,ChB MD
role: Principal Investigator
affiliation: Alexandria University
last name: Mohammad Hazem Ahmad Sabry, MB,ChB
phone: 01062718827
email: mohammad_hazem@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Jannati Y, Bagheri-Nesami M, Sohrabi M, Yazdani-Cherati J, Mazdarani S. Factors associated with post-surgical delirium in patients undergoing open heart surgery. Oman Med J. 2014 Sep;29(5):340-5. doi: 10.5001/omj.2014.91.
PMID: 25337310
responsible party type: Principal Investigator
investigator affiliation: University of Alexandria
investigator full name: Mohammad Hazem I. Ahmad Sabry
investigator title: Lecturer of Anesthesia
mesh term: Delirium
sharing ipd: No