<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/NCT04483765</url>
  </required_header>
  <id_info>
    <org_study_id>E1-20-787</org_study_id>
    <nct_id>NCT04483765</nct_id>
  </id_info>
  <brief_title>Shock Index, Modified Shock Index and Age-related Shock Index for Predicting Post-spinal Hypotension in Elderly Patients</brief_title>
  <official_title>Does Shock Index, Modified Shock Index and Age-Related Shock Index Have a Predictive Value in Predicting the Risk of Post-spinal Hypotension in Elderly Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara City Hospital Bilkent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara City Hospital Bilkent</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>
      Aim of this prospective observational study is to investigate whether shock index(SI),&#xD;
      modified shock index(MSI) and age related shock index(ASI) have any predictive value in&#xD;
      predicting post-spinal hypotension which may develop in patients over 65 years of age, who&#xD;
      are planned to undergo transurethral resection of the prostate (TURP) and transurethral&#xD;
      resection of the bladder (TURB) surgery under spinal anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the aging process, many important changes occur in the cardiovascular system. In&#xD;
      elderly patients undergoing surgery, systemic vascular resistance is generally high but&#xD;
      accompanying dehydration is a very common condition. The hemodynamic status of these patients&#xD;
      may be compromised during spinal anesthesia due to the decrease in both systemic vascular&#xD;
      resistance (SVR) and cardiac preload. Intraoperative hypotension may develop after spinal&#xD;
      anesthesia. Intraoperative hypotension can prolong hospital stay by causing serious&#xD;
      complications, and it can significantly affect mortality rates. Predicting hypotension which&#xD;
      may develop after spinal anesthesia, can save time to decide, prepare and apply preventive&#xD;
      interventions.&#xD;
&#xD;
      Shock index (SI) has been defined as the ratio of heart rate (HR) to systolic blood pressure&#xD;
      (SBP). SI is an easy and non-invasive marker used in hypovolemia and early diagnosis of&#xD;
      shock. SI is usually &lt;0.7. In case of acute hypovolemia and circulatory failure, this ratio&#xD;
      increases. It has been stated that in critical patients, diastolic blood pressure (DBP) will&#xD;
      drop earlier than SBP, and the mean blood pressure will be a more accurate marker to assess&#xD;
      the severity of the disease. For this reason, the modified shock index (MSI), which is&#xD;
      obtained by dividing the heart rate by the mean arterial pressure (MAP), has been defined.&#xD;
      MSI&gt; 1.3 indicates a hypodynamic state.&#xD;
&#xD;
      The Age Shock Index (ASI) is defined by multiplying SI by age. In trauma patients, this index&#xD;
      has been shown to correlate with a higher mortality rate with an increase greater than 50.&#xD;
      Since age affects the physiological reserve negatively, it has been stated that ASI is a&#xD;
      better predictor of 48-hour mortality compared to heart rate, SBP or SI. In studies&#xD;
      evaluating ASI, SI and MSI to predict post-intubation hypotension; pre-intubation SI, MSI,&#xD;
      ASI values have been shown to be the independent predictors of post-intubation hypotension.&#xD;
&#xD;
      Aim of this prospective observational study is to investigate whether SI, MSI and ASI have&#xD;
      any predictive value in predicting post-spinal hypotension which may develop in patients over&#xD;
      65 years of age, who are planned to undergo transurethral resection of the prostate (TURP)&#xD;
      and transurethral resection of the bladder (TURB) surgery under spinal anesthesia.&#xD;
&#xD;
      The secondary objective is to compare the two groups in terms of preoperative and&#xD;
      postoperative blood tests, and to determine whether the patients were admitted to intensive&#xD;
      care or postanesthesia care unit. If the patient was admitted, length of unit and hospital&#xD;
      stay and postoperative complications (if developed any) will be recorded. In addition, the&#xD;
      investigators will examine whether intraoperative hypotension has any negative effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">November 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2020</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>SI</measure>
    <time_frame>preoperative</time_frame>
    <description>shock index: defined as the ratio of heart rate (HR) to systolic blood pressure (SBP)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MSI</measure>
    <time_frame>preoperative</time_frame>
    <description>Modified Shock İndex: obtained by dividing the heart rate by the mean arterial pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ASI</measure>
    <time_frame>preoperative</time_frame>
    <description>Age Shock Index (ASI) is defined by multiplying shock index(SI) by age</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CCI</measure>
    <time_frame>preoperative</time_frame>
    <description>Charlson Comorbidity Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>length of hospital stay after operation</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Anesthesia Morbidity</condition>
  <condition>Procedural Hypotension</condition>
  <condition>Intraoperative Hypotension</condition>
  <condition>Geriatrics</condition>
  <arm_group>
    <arm_group_label>post-spinal hypotension</arm_group_label>
    <description>Patients with a fall in SBP by 25% of the preoperative baseline or an absolute value &lt;90 mm of Hg; MAP ≤65 mmHg after spinal anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>post-spinal normotension</arm_group_label>
    <description>Patients with Fall of SBP&lt;%25 of the preoperative value or absolute value &gt;90 mm Hg, MAP&gt;65 mmHg</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>spinal anesthesia</intervention_name>
    <description>patients undergoing transurethral resection of the prostate (TURP) and transurethral resection of the bladder (TURB) surgery under spinal anesthesia.</description>
    <arm_group_label>post-spinal hypotension</arm_group_label>
    <arm_group_label>post-spinal normotension</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Paients undergo transurethral resection of the prostate (TURP) and transurethral resection&#xD;
        of the bladder (TURB) surgery under spinal anesthesia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥65 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        duration of operation&gt;120 minutes ASA&gt;3&#xD;
&#xD;
          -  Patients with valvular heart disease that disrupts hemodynamics&#xD;
&#xD;
          -  Patients with arrhythmia (such as atrial fibrillation with rapid ventricular rate)&#xD;
             that disrupts hemodynamics&#xD;
&#xD;
          -  severe heart failure&#xD;
&#xD;
          -  mental and motor problems&#xD;
&#xD;
          -  neuropsychiatric disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>İsmail Aytac</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ankara City Hospital Anesthesiology Department</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>İsmail Aytac</last_name>
    <phone>05056340369</phone>
    <email>aytacismail1972@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ankara City Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06800</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>İsmail Aytac</last_name>
      <phone>+905056340369</phone>
      <email>aytacismail1972@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara City Hospital Bilkent</investigator_affiliation>
    <investigator_full_name>ismail aytaç</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>geriatric anesthesia</keyword>
  <keyword>post-spinal hypotension</keyword>
  <keyword>Intraoperative Hypotension</keyword>
  <keyword>spinal anesthesia</keyword>
  <keyword>shock index</keyword>
  <keyword>modified shock index</keyword>
  <keyword>age-related shock index</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT04483765
org study id: E1-20-787
nct id: NCT04483765
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim of this prospective observational study is to investigate whether shock index(SI),
      modified shock index(MSI) and age related shock index(ASI) have any predictive value in
      predicting post-spinal hypotension which may develop in patients over 65 years of age, who
      are planned to undergo transurethral resection of the prostate (TURP) and transurethral
      resection of the bladder (TURB) surgery under spinal anesthesia.
During the aging process, many important changes occur in the cardiovascular system. In
      elderly patients undergoing surgery, systemic vascular resistance is generally high but
      accompanying dehydration is a very common condition. The hemodynamic status of these patients
      may be compromised during spinal anesthesia due to the decrease in both systemic vascular
      resistance (SVR) and cardiac preload. Intraoperative hypotension may develop after spinal
      anesthesia. Intraoperative hypotension can prolong hospital stay by causing serious
      complications, and it can significantly affect mortality rates. Predicting hypotension which
      may develop after spinal anesthesia, can save time to decide, prepare and apply preventive
      interventions.

      Shock index (SI) has been defined as the ratio of heart rate (HR) to systolic blood pressure
      (SBP). SI is an easy and non-invasive marker used in hypovolemia and early diagnosis of
      shock. SI is usually <0.7. In case of acute hypovolemia and circulatory failure, this ratio
      increases. It has been stated that in critical patients, diastolic blood pressure (DBP) will
      drop earlier than SBP, and the mean blood pressure will be a more accurate marker to assess
      the severity of the disease. For this reason, the modified shock index (MSI), which is
      obtained by dividing the heart rate by the mean arterial pressure (MAP), has been defined.
      MSI> 1.3 indicates a hypodynamic state.

      The Age Shock Index (ASI) is defined by multiplying SI by age. In trauma patients, this index
      has been shown to correlate with a higher mortality rate with an increase greater than 50.
      Since age affects the physiological reserve negatively, it has been stated that ASI is a
      better predictor of 48-hour mortality compared to heart rate, SBP or SI. In studies
      evaluating ASI, SI and MSI to predict post-intubation hypotension; pre-intubation SI, MSI,
      ASI values have been shown to be the independent predictors of post-intubation hypotension.

      Aim of this prospective observational study is to investigate whether SI, MSI and ASI have
      any predictive value in predicting post-spinal hypotension which may develop in patients over
      65 years of age, who are planned to undergo transurethral resection of the prostate (TURP)
      and transurethral resection of the bladder (TURB) surgery under spinal anesthesia.

      The secondary objective is to compare the two groups in terms of preoperative and
      postoperative blood tests, and to determine whether the patients were admitted to intensive
      care or postanesthesia care unit. If the patient was admitted, length of unit and hospital
      stay and postoperative complications (if developed any) will be recorded. In addition, the
      investigators will examine whether intraoperative hypotension has any negative effects.
observational model: Cohort
time perspective: Prospective
measure: SI
time frame: preoperative
description: shock index: defined as the ratio of heart rate (HR) to systolic blood pressure (SBP)
measure: MSI
time frame: preoperative
description: Modified Shock İndex: obtained by dividing the heart rate by the mean arterial pressure
measure: ASI
time frame: preoperative
description: Age Shock Index (ASI) is defined by multiplying shock index(SI) by age
measure: CCI
time frame: preoperative
description: Charlson Comorbidity Index
measure: length of hospital stay
time frame: through study completion, an average of 3 months
description: length of hospital stay after operation
arm group label: post-spinal hypotension
description: Patients with a fall in SBP by 25% of the preoperative baseline or an absolute value <90 mm of Hg; MAP ≤65 mmHg after spinal anesthesia
arm group label: post-spinal normotension
description: Patients with Fall of SBP<%25 of the preoperative value or absolute value >90 mm Hg, MAP>65 mmHg
intervention type: Procedure
intervention name: spinal anesthesia
description: patients undergoing transurethral resection of the prostate (TURP) and transurethral resection of the bladder (TURB) surgery under spinal anesthesia.
arm group label: post-spinal hypotension
arm group label: post-spinal normotension
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: 85 Years
healthy volunteers: No
last name: İsmail Aytac
role: Principal Investigator
affiliation: Ankara City Hospital Anesthesiology Department
last name: İsmail Aytac
phone: 05056340369
email: aytacismail1972@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ankara City Hospital Bilkent
investigator full name: ismail aytaç
investigator title: Principal Investigator
mesh term: Hypotension
mesh term: Shock
mesh term: Anesthetics
sharing ipd: No