<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/NCT03777150</url>
  </required_header>
  <id_info>
    <org_study_id>ICU postoperative care</org_study_id>
    <nct_id>NCT03777150</nct_id>
  </id_info>
  <brief_title>Is There a Benefit of Postoperative ICU Management After Elective Surgery in Critical Ill Patients?</brief_title>
  <official_title>Is There a Benefit of Postoperative ICU Management After Elective Surgery in Terms of Patient's Outcome, Length of Hospital Stay, Complications and Cost?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saint Savvas Anticancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saint Savvas Anticancer 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>
      Postoperative care of high risk patients in the Intensive Care Unit (ICU) has for long been&#xD;
      considered to be the gold standard of care in terms of reducing perioperative mortality.New&#xD;
      evidence from a 7-day cohort study involving 27 countries comes to question this practice.&#xD;
      The primary objective of our study is to detect any benefit of postoperative ICU care after&#xD;
      elective surgery in terms of patient's outcome, length of hospital stay, complications and&#xD;
      cost.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective analysis of high perioperative risk patients that are about to be subjected&#xD;
      into an elective operation will be included into the study. They will be allocated into two&#xD;
      groups. Group ICU patients are those that are admitted into the ICU for postoperative care&#xD;
      and those that are admitted into a standard ward consist Group Ward. Demographic data, the&#xD;
      length of hospital stay, the outcome, the need of mechanical ventilation, the complications&#xD;
      and the total cost will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 10, 2018</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Group I: admitted into the ICU for postoperative care Group II: admitted into a standard ward for postoperative care</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total length of hospital stay</measure>
    <time_frame>From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months</time_frame>
    <description>The total length of patient's hospital stay will be recorded</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preoperative length of hospital stay</measure>
    <time_frame>From date of hospital admission until the date of operation or date of death from any cause, whichever came first, assessed up to 6 months</time_frame>
    <description>The preoperative length of patient's hospital stay will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative length of hospital stay</measure>
    <time_frame>From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months</time_frame>
    <description>The postoperative length of patient's hospital stay will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months</time_frame>
    <description>All postoperative complications will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's outcome at 28 days postoperatively</measure>
    <time_frame>From the first postoperative day until 28 days postoperatively</time_frame>
    <description>28 day postoperative mortality will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cost of hospital care</measure>
    <time_frame>From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months</time_frame>
    <description>The total cost of hospital care will be recorded for every patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative cost of hospital care</measure>
    <time_frame>From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months</time_frame>
    <description>The postoperative cost of hospital care will be recorded for every patient</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Postoperative Care</condition>
  <condition>Intensive Care</condition>
  <arm_group>
    <arm_group_label>Group ICU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group ICU:patients are admitted directly into the ICU for postoperative care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Ward</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group Ward:patients are admitted directly into the standard ward for postoperative care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Postoperative care in Intensive care unit (ICU)</intervention_name>
    <description>Postoperative care in Intensive care unit (ICU)</description>
    <arm_group_label>Group ICU</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Postoperative care in standard ward</intervention_name>
    <description>Postoperative care in standard ward</description>
    <arm_group_label>Group Ward</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients that will be scheduled for an elective operation and are considered to be&#xD;
             in a high perioperative risk&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that are operated on an emergency basis&#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>Anna Efthimiou, Head of the department</last_name>
    <role>Study Director</role>
    <affiliation>Saint Savvas Anticancer hospital of Athens</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Georgia Micha, MD, PhD</last_name>
    <phone>6974828254</phone>
    <phone_ext>0030</phone_ext>
    <email>mgeo3@yahoo.gr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vasiliki Chantziara, MD, PHD</last_name>
    <phone>6937173376</phone>
    <phone_ext>0030</phone_ext>
    <email>vchantziara@yahoo.gr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Saint Savvas Anticancer Hospital of Athens</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Georgia Micha, MD, MSc, PhD</last_name>
      <phone>+306974828254</phone>
    </contact>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>December 14, 2018</last_update_submitted>
  <last_update_submitted_qc>December 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saint Savvas Anticancer Hospital</investigator_affiliation>
    <investigator_full_name>Georgia Micha</investigator_full_name>
    <investigator_title>Anesthesiologist,MD, PhD Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Intensive care</keyword>
  <keyword>postoperative care</keyword>
  <keyword>elective surgery</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03777150
org study id: ICU postoperative care
nct id: NCT03777150
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Postoperative care of high risk patients in the Intensive Care Unit (ICU) has for long been
      considered to be the gold standard of care in terms of reducing perioperative mortality.New
      evidence from a 7-day cohort study involving 27 countries comes to question this practice.
      The primary objective of our study is to detect any benefit of postoperative ICU care after
      elective surgery in terms of patient's outcome, length of hospital stay, complications and
      cost.
A prospective analysis of high perioperative risk patients that are about to be subjected
      into an elective operation will be included into the study. They will be allocated into two
      groups. Group ICU patients are those that are admitted into the ICU for postoperative care
      and those that are admitted into a standard ward consist Group Ward. Demographic data, the
      length of hospital stay, the outcome, the need of mechanical ventilation, the complications
      and the total cost will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group I: admitted into the ICU for postoperative care Group II: admitted into a standard ward for postoperative care
primary purpose: Supportive Care
masking: None (Open Label)
measure: Total length of hospital stay
time frame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months
description: The total length of patient's hospital stay will be recorded
measure: Preoperative length of hospital stay
time frame: From date of hospital admission until the date of operation or date of death from any cause, whichever came first, assessed up to 6 months
description: The preoperative length of patient's hospital stay will be recorded
measure: Postoperative length of hospital stay
time frame: From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months
description: The postoperative length of patient's hospital stay will be recorded
measure: Postoperative complications
time frame: From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months
description: All postoperative complications will be recorded
measure: Patient's outcome at 28 days postoperatively
time frame: From the first postoperative day until 28 days postoperatively
description: 28 day postoperative mortality will be recorded
measure: Total cost of hospital care
time frame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months
description: The total cost of hospital care will be recorded for every patient
measure: Postoperative cost of hospital care
time frame: From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months
description: The postoperative cost of hospital care will be recorded for every patient
arm group label: Group ICU
arm group type: Experimental
description: Group ICU:patients are admitted directly into the ICU for postoperative care
arm group label: Group Ward
arm group type: Experimental
description: Group Ward:patients are admitted directly into the standard ward for postoperative care
intervention type: Other
intervention name: Postoperative care in Intensive care unit (ICU)
description: Postoperative care in Intensive care unit (ICU)
arm group label: Group ICU
intervention type: Other
intervention name: Postoperative care in standard ward
description: Postoperative care in standard ward
arm group label: Group Ward
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anna Efthimiou, Head of the department
role: Study Director
affiliation: Saint Savvas Anticancer hospital of Athens
last name: Georgia Micha, MD, PhD
phone: 6974828254
phone ext: 0030
email: mgeo3@yahoo.gr
last name: Vasiliki Chantziara, MD, PHD
phone: 6937173376
phone ext: 0030
email: vchantziara@yahoo.gr
facility: 
status: Recruiting
contact: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Saint Savvas Anticancer Hospital
investigator full name: Georgia Micha
investigator title: Anesthesiologist,MD, PhD Principal Investigator
sharing ipd: Undecided