xml: <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/NCT05995925</url>
    </required_header>
    <id_info>
      <org_study_id>2023.198.IRB1.065</org_study_id>
      <nct_id>NCT05995925</nct_id>
    </id_info>
    <brief_title>Observational Study for Perioperative Care of Patients Requiring ICU (OPICU)</brief_title>
    <acronym>OPICU</acronym>
    <official_title>Observational Study for Perioperative Care of Patients Requiring ICU (OPICU)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Koç University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Koç University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This clinical trial will be carried out as a national multicenter observational cohort trial&#xD;
        in Turkey. Our starting point is the need to triage postoperative patients daily due to the&#xD;
        limited intensive care unit (ICU) bed capacity. Our hypothesis is that patients requiring&#xD;
        emergency or unplanned ICU admission generally meet the ICU admission criteria. However,&#xD;
        postoperative patients admitted to the ICU for planned reasons often do not meet the ICU&#xD;
        admission criteria and can be monitored in a lower-level unit (Postoperative Care Unit -&#xD;
        PACU) for close observation purposes.&#xD;
  &#xD;
        The primary aim is to assess the efficient utilization of ICU beds. We try to compare the&#xD;
        treatments provided during ICU follow-up, for planned and unplanned patients requiring ICU&#xD;
        admission. Our secondary outcome is to identify criteria that can predict ICU indications&#xD;
        based on patients' preoperative characteristics and evaluate the postoperative complications&#xD;
        according to the Clavien-Dindo classification.&#xD;
  &#xD;
        Our aim is to categorize patients admitted to the ICU into two groups: planned and&#xD;
        unplanned/emergency cases and compare the necessity of ICU care between these two groups. The&#xD;
        need for ICU treatment will be determined based on the criteria established in the following*&#xD;
        study. The presence of any of these criteria will indicate the need for ICU admission, while&#xD;
        the absence of these criteria may identify patients admitted to the ICU only for monitoring&#xD;
        purposes (i.e., unnecessary ICU admissions).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Surgical cases involving patients over 18 years of age requiring postoperative intensive care&#xD;
        will be included (including patients who were admitted urgently, or patients that is planned&#xD;
        but not admitted to ICU after the surgery).&#xD;
  &#xD;
        Cardiac surgery cases, outpatient cases, pediatric surgery cases, patients undergoing surgery&#xD;
        while hospitalized in the ICU, patients undergoing only interventional procedures, and those&#xD;
        who do not provide consent will be excluded from the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">April 4, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 4, 2024</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>Effective use of ICU</measure>
      <time_frame>From 1 day before the surgery to the 30th day after the surgery.</time_frame>
      <description>To take a picture of the use of ICU beds in postoperative patients in Turkish intensive care units.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rates of postoperative complications</measure>
      <time_frame>From the end of the surgery until discharge from the hospital</time_frame>
      <description>They will be assessed postoperatively using Clavien- Dindo classification</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of ICU stay</measure>
      <time_frame>From the end of the surgery until discharge from the ICU</time_frame>
      <description>The patient will be followed up from admission to the ICU until discharge from the ICU</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay.</measure>
      <time_frame>From the end of the surgery until discharge from the hospital</time_frame>
      <description>The patient will be followed up from admission to the ICU until discharge from the hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ICU mortality</measure>
      <time_frame>From the end of the surgery until discharge from the ICU</time_frame>
      <description>The patient will be followed up from admission to the ICU until discharge from the ICU</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>30-day hospital mortality</measure>
      <time_frame>From the end of the surgery until discharge from the hospital</time_frame>
      <description>The patient will be followed up from admission to the ICU until his discharge from the hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Best scoring system for ICU admission</measure>
      <time_frame>Preoperative from hospital admission until the patient's discharge from hospital following surgery.</time_frame>
      <description>Identifying the best scoring system for ICU admission by comparing different scoring systems.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Epidemiology of postoperative ICU admitted patients</measure>
      <time_frame>From preoperative hospital admission until discharge from the hospital</time_frame>
      <description>Defining groups in postoperative patients according to their region or type of surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Risk factors or criteria for ICU admission after the surgery</measure>
      <time_frame>From preoperative hospital admission until discharge from the hospital</time_frame>
      <description>During the entire perioperative process, the patient will be closely observed, vital signs, treatments and complications will be recorded.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">1300</enrollment>
    <condition>Indication, Unlabeled</condition>
    <condition>Complication,Postoperative</condition>
    <arm_group>
      <arm_group_label>Patients with planned ICU admission</arm_group_label>
      <description>Patients with preoperative planned ICU admission</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients with unplanned ICU admission</arm_group_label>
      <description>Patients with preoperative unplanned ICU admission</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Clinical Observation</intervention_name>
      <description>Clinical Observation</description>
      <arm_group_label>Patients with planned ICU admission</arm_group_label>
      <arm_group_label>Patients with unplanned ICU admission</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population consists of patients requiring intensive care treatment in the&#xD;
          postoperative period.&#xD;
  &#xD;
          The study population comprises individuals who have undergone surgery and require intensive&#xD;
          care, regardless of whether their admission to the ICU was planned or unplanned.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Major elective/emergency surgical procedures&#xD;
  &#xD;
            -  Planned, unplanned, emergent surgical procedures, planned but not admitted to the ICU&#xD;
               after the operation.&#xD;
  &#xD;
            -  Patients who planned but not transferred to the ICU will also be followed/ included&#xD;
               postoperatively&#xD;
  &#xD;
            -  Informed Consent&#xD;
  &#xD;
            -  Major surgeries will be targeted within the broad subgroup domains of gynecology,&#xD;
               neurosurgery, thoracic, urology, orthopedics/trauma, and abdominal surgery.&#xD;
  &#xD;
            -  Unplanned but admitted to ICU after surgery in 48 hrs.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Day-case surgery&#xD;
  &#xD;
            -  Cardiac surgery&#xD;
  &#xD;
            -  Pediatric surgery&#xD;
  &#xD;
            -  Patients who were already staying in ICU and planned to be operated on&#xD;
  &#xD;
            -  Denial of informed consent&#xD;
  &#xD;
            -  All interventional procedures&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nahit Cakar, Prof, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Koç University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Evren Senturk, Prof, MD</last_name>
      <phone>+90 212 338 10 00</phone>
      <email>esenturk@ku.edu.tr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Bulent Gucyetmez, Assoc.Prof</last_name>
      <phone>+90 212 468 44 44</phone>
      <email>bulentgucyetmez@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Koc University</name>
        <address>
          <city>Istanbul</city>
          <zip>34450</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>Evren Senturk, Prof, MD</last_name>
        <phone>+90 212 338 10 00</phone>
        <email>esenturk@ku.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <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>Jerath A, Laupacis A, Austin PC, Wunsch H, Wijeysundera DN. Intensive care utilization following major noncardiac surgical procedures in Ontario, Canada: a population-based study. Intensive Care Med. 2018 Sep;44(9):1427-1435. doi: 10.1007/s00134-018-5330-6. Epub 2018 Jul 27.</citation>
      <PMID>30054691</PMID>
    </results_reference>
    <results_reference>
      <citation>Zampieri FG, Lone NI, Bagshaw SM. Admission to intensive care unit after major surgery. Intensive Care Med. 2023 May;49(5):575-578. doi: 10.1007/s00134-023-07026-7. Epub 2023 Mar 22. No abstract available.</citation>
      <PMID>36947198</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Koç University</investigator_affiliation>
      <investigator_full_name>Evren Senturk</investigator_full_name>
      <investigator_title>Prof. Dr.</investigator_title>
    </responsible_party>
    <keyword>Intensive Care</keyword>
    <keyword>Triage</keyword>
    <keyword>Postoperative period</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Postoperative Complications</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05995925
  org study id: 2023.198.IRB1.065
  nct id: NCT05995925
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial will be carried out as a national multicenter observational cohort trial
        in Turkey. Our starting point is the need to triage postoperative patients daily due to the
        limited intensive care unit (ICU) bed capacity. Our hypothesis is that patients requiring
        emergency or unplanned ICU admission generally meet the ICU admission criteria. However,
        postoperative patients admitted to the ICU for planned reasons often do not meet the ICU
        admission criteria and can be monitored in a lower-level unit (Postoperative Care Unit -
        PACU) for close observation purposes.
  
        The primary aim is to assess the efficient utilization of ICU beds. We try to compare the
        treatments provided during ICU follow-up, for planned and unplanned patients requiring ICU
        admission. Our secondary outcome is to identify criteria that can predict ICU indications
        based on patients' preoperative characteristics and evaluate the postoperative complications
        according to the Clavien-Dindo classification.
  
        Our aim is to categorize patients admitted to the ICU into two groups: planned and
        unplanned/emergency cases and compare the necessity of ICU care between these two groups. The
        need for ICU treatment will be determined based on the criteria established in the following*
        study. The presence of any of these criteria will indicate the need for ICU admission, while
        the absence of these criteria may identify patients admitted to the ICU only for monitoring
        purposes (i.e., unnecessary ICU admissions).
  Surgical cases involving patients over 18 years of age requiring postoperative intensive care
        will be included (including patients who were admitted urgently, or patients that is planned
        but not admitted to ICU after the surgery).
  
        Cardiac surgery cases, outpatient cases, pediatric surgery cases, patients undergoing surgery
        while hospitalized in the ICU, patients undergoing only interventional procedures, and those
        who do not provide consent will be excluded from the study.
  observational model: Cohort
  time perspective: Prospective
  measure: Effective use of ICU
  time frame: From 1 day before the surgery to the 30th day after the surgery.
  description: To take a picture of the use of ICU beds in postoperative patients in Turkish intensive care units.
  measure: Rates of postoperative complications
  time frame: From the end of the surgery until discharge from the hospital
  description: They will be assessed postoperatively using Clavien- Dindo classification
  measure: Length of ICU stay
  time frame: From the end of the surgery until discharge from the ICU
  description: The patient will be followed up from admission to the ICU until discharge from the ICU
  measure: Length of hospital stay.
  time frame: From the end of the surgery until discharge from the hospital
  description: The patient will be followed up from admission to the ICU until discharge from the hospital
  measure: ICU mortality
  time frame: From the end of the surgery until discharge from the ICU
  description: The patient will be followed up from admission to the ICU until discharge from the ICU
  measure: 30-day hospital mortality
  time frame: From the end of the surgery until discharge from the hospital
  description: The patient will be followed up from admission to the ICU until his discharge from the hospital
  measure: Best scoring system for ICU admission
  time frame: Preoperative from hospital admission until the patient's discharge from hospital following surgery.
  description: Identifying the best scoring system for ICU admission by comparing different scoring systems.
  measure: Epidemiology of postoperative ICU admitted patients
  time frame: From preoperative hospital admission until discharge from the hospital
  description: Defining groups in postoperative patients according to their region or type of surgery
  measure: Risk factors or criteria for ICU admission after the surgery
  time frame: From preoperative hospital admission until discharge from the hospital
  description: During the entire perioperative process, the patient will be closely observed, vital signs, treatments and complications will be recorded.
  arm group label: Patients with planned ICU admission
  description: Patients with preoperative planned ICU admission
  arm group label: Patients with unplanned ICU admission
  description: Patients with preoperative unplanned ICU admission
  intervention type: Other
  intervention name: Clinical Observation
  description: Clinical Observation
  arm group label: Patients with planned ICU admission
  arm group label: Patients with unplanned ICU admission
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Nahit Cakar, Prof, MD
  role: Study Chair
  affiliation: Koç University
  last name: Evren Senturk, Prof, MD
  phone: +90 212 338 10 00
  email: esenturk@ku.edu.tr
  last name: Bulent Gucyetmez, Assoc.Prof
  phone: +90 212 468 44 44
  email: bulentgucyetmez@gmail.com
  facility: 
  contact: 
  country: Turkey
  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: Jerath A, Laupacis A, Austin PC, Wunsch H, Wijeysundera DN. Intensive care utilization following major noncardiac surgical procedures in Ontario, Canada: a population-based study. Intensive Care Med. 2018 Sep;44(9):1427-1435. doi: 10.1007/s00134-018-5330-6. Epub 2018 Jul 27.
  PMID: 30054691
  citation: Zampieri FG, Lone NI, Bagshaw SM. Admission to intensive care unit after major surgery. Intensive Care Med. 2023 May;49(5):575-578. doi: 10.1007/s00134-023-07026-7. Epub 2023 Mar 22. No abstract available.
  PMID: 36947198
  responsible party type: Principal Investigator
  investigator affiliation: Koç University
  investigator full name: Evren Senturk
  investigator title: Prof. Dr.
  mesh term: Postoperative Complications
  sharing ipd: Undecided