<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/NCT03805230</url>
  </required_header>
  <id_info>
    <org_study_id>SQUEEZE</org_study_id>
    <nct_id>NCT03805230</nct_id>
  </id_info>
  <brief_title>Postoperative Vasopressor Usage: SQUEEZE</brief_title>
  <acronym>SQUEEZE</acronym>
  <official_title>Postoperative Vasopressor Usage : a Prospective International Observational Study (SQUEEZE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Society of Anaesthesiology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Society of Anaesthesiology</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>
      A prospective multi-centre international observational study of postoperative vasopressor&#xD;
      use, designed to answer the question: 'What is the proportion of patients that receive&#xD;
      vasopressor infusions? In the management of these patients;&#xD;
&#xD;
        -  Are there variations in the practice between clinicians, hospitals or countries? If yes,&#xD;
           are they associated with clinical outcome?&#xD;
&#xD;
        -  What are the health economic impacts associated with receiving vasopressors?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative hypotension is a common occurrence following major non-cardiac surgery and the&#xD;
      use of vasopressors in the postoperative period to support blood pressure following&#xD;
      optimisation of fluid status is commonplace. Receipt of infused vasopressors postoperatively&#xD;
      is considered as a surrogate indicator of significant vasodilation. However, the incidence of&#xD;
      postoperative vasopressor therapy has never been described.&#xD;
&#xD;
      By contrast to septic shock, there is no uniform definition of postoperative vasoplegia.&#xD;
      Receipt of any amount of vasopressor would provide an objective dichotomous definition but a&#xD;
      limitation would be the inability to differentiate degrees of vasodilation. Use of a&#xD;
      threshold dose of infused vasopressor to determine a definition is uncomfortably arbitrary.&#xD;
      There have been trials of different vasopressors to treat postoperative vasoplegia in cardiac&#xD;
      surgical patients and we intend to gather data to inform future design in noncardiac surgery.&#xD;
&#xD;
      In addition, there is evidence of substantial variation in the management of postoperative&#xD;
      hypotension between centres, countries and continents. The variation is in assessment&#xD;
      (cardiac output and invasive monitoring) and environment (post-operative care units,&#xD;
      high-dependency units, ICUs) and management (use and choice of fluids and&#xD;
      vasopressors/inotropes). We hypothesise that there is also variation in the incidence of&#xD;
      organ dysfunction and the use of organ support, and in clinical outcomes including duration&#xD;
      of stay and mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 5, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</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>Prevalence of postoperative vasopressor usage in a none cardiac surgical population.</measure>
    <time_frame>A the primary endpoint is the proportion of patients receiving vasopressor infusions that start between 1 and 24 hours postoperatively</time_frame>
    <description>1. What proportions of patients receive infused vasopressors postoperatively?</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40000</enrollment>
  <condition>Surgical Procedures, Operative</condition>
  <condition>Vasopressor</condition>
  <arm_group>
    <arm_group_label>Cohort A</arm_group_label>
    <description>all patients admitted to participating hospitals during 7 consecutive days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B</arm_group_label>
    <description>30 sequential patients with a single additional inclusion criterion</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult Patients undergoing any non-cardiac surgical procedure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing surgery (may be planned or unplanned)&#xD;
&#xD;
          -  No plans for return home on the day of surgery, for medical reasons&#xD;
&#xD;
          -  Age ≥ 18 on day of surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac surgery&#xD;
&#xD;
          -  Obstetric surgery&#xD;
&#xD;
          -  Transplant surgery&#xD;
&#xD;
          -  Receiving long-term infusions of vasoactive drugs, such as epoprostenol&#xD;
&#xD;
          -  Mechanical circulatory support: ventricular assist device, intra-aortic balloon pump,&#xD;
             artificial heart or similar&#xD;
&#xD;
          -  Already been enrolled in Squeeze&#xD;
&#xD;
        For Cohort B - One additional inclusion criterion:&#xD;
&#xD;
          -  Receiving infusion of vasopressors that continues after the patient has left the&#xD;
             operating room.&#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>Ib Jammer, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Haukeland University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ben Creagh-Brown</last_name>
    <role>Study Chair</role>
    <affiliation>Royal Surrey County Hospital NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sylvia Daamen</last_name>
    <phone>003222109414</phone>
    <email>research@esaic.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pierre Harlet</last_name>
    <phone>3222105773</phone>
    <email>research@esaic.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital Knappschaftskrankenhaus Bochum</name>
      <address>
        <city>Bochum</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Wilhelmina Hospital Assen</name>
      <address>
        <city>Assen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Constanze Abusaris</last_name>
      <email>Constanze.Abusaris@wza.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>https://www.esaic.org/research/clinical-trial-network/squeeze/</url>
    <description>ESAIC Clinical Trial Network website</description>
  </link>
  <reference>
    <citation>Moonesinghe SR, Wong DJN, Farmer L, Shawyer R, Myles PS, Harris SK; SNAP-2 Project team and Steering Group. SNAP-2 EPICCS: the second Sprint National Anaesthesia Project-EPIdemiology of Critical Care after Surgery: protocol for an international observational cohort study. BMJ Open. 2017 Sep 7;7(9):e017690. doi: 10.1136/bmjopen-2017-017690.</citation>
    <PMID>28882925</PMID>
  </reference>
  <reference>
    <citation>Global patient outcomes after elective surgery: prospective cohort study in 27 low-, middle- and high-income countries. Br J Anaesth. 2017 Sep 1;119(3):553. doi: 10.1093/bja/aew472. No abstract available.</citation>
    <PMID>28498884</PMID>
  </reference>
  <reference>
    <citation>Kho ME, Duffett M, Willison DJ, Cook DJ, Brouwers MC. Written informed consent and selection bias in observational studies using medical records: systematic review. BMJ. 2009 Mar 12;338:b866. doi: 10.1136/bmj.b866.</citation>
    <PMID>19282440</PMID>
  </reference>
  <reference>
    <citation>Biccard BM, Madiba TE, Kluyts HL, Munlemvo DM, Madzimbamuto FD, Basenero A, Gordon CS, Youssouf C, Rakotoarison SR, Gobin V, Samateh AL, Sani CM, Omigbodun AO, Amanor-Boadu SD, Tumukunde JT, Esterhuizen TM, Manach YL, Forget P, Elkhogia AM, Mehyaoui RM, Zoumeno E, Ndayisaba G, Ndasi H, Ndonga AKN, Ngumi ZWW, Patel UP, Ashebir DZ, Antwi-Kusi AAK, Mbwele B, Sama HD, Elfiky M, Fawzy MA, Pearse RM; African Surgical Outcomes Study (ASOS) investigators. Perioperative patient outcomes in the African Surgical Outcomes Study: a 7-day prospective observational cohort study. Lancet. 2018 Apr 21;391(10130):1589-1598. doi: 10.1016/S0140-6736(18)30001-1. Epub 2018 Jan 3.</citation>
    <PMID>29306587</PMID>
  </reference>
  <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>
  </reference>
  <reference>
    <citation>Lambden S, Creagh-Brown BC, Hunt J, Summers C, Forni LG. Definitions and pathophysiology of vasoplegic shock. Crit Care. 2018 Jul 6;22(1):174. doi: 10.1186/s13054-018-2102-1.</citation>
    <PMID>29980217</PMID>
  </reference>
  <reference>
    <citation>Hajjar LA, Vincent JL, Barbosa Gomes Galas FR, Rhodes A, Landoni G, Osawa EA, Melo RR, Sundin MR, Grande SM, Gaiotto FA, Pomerantzeff PM, Dallan LO, Franco RA, Nakamura RE, Lisboa LA, de Almeida JP, Gerent AM, Souza DH, Gaiane MA, Fukushima JT, Park CL, Zambolim C, Rocha Ferreira GS, Strabelli TM, Fernandes FL, Camara L, Zeferino S, Santos VG, Piccioni MA, Jatene FB, Costa Auler JO Jr, Filho RK. Vasopressin versus Norepinephrine in Patients with Vasoplegic Shock after Cardiac Surgery: The VANCS Randomized Controlled Trial. Anesthesiology. 2017 Jan;126(1):85-93. doi: 10.1097/ALN.0000000000001434.</citation>
    <PMID>27841822</PMID>
  </reference>
  <reference>
    <citation>Abbott TEF, Fowler AJ, Pelosi P, Gama de Abreu M, Moller AM, Canet J, Creagh-Brown B, Mythen M, Gin T, Lalu MM, Futier E, Grocott MP, Schultz MJ, Pearse RM; StEP-COMPAC Group. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications. Br J Anaesth. 2018 May;120(5):1066-1079. doi: 10.1016/j.bja.2018.02.007. Epub 2018 Mar 27.</citation>
    <PMID>29661384</PMID>
  </reference>
  <reference>
    <citation>Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.</citation>
    <PMID>25058504</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>February 15, 2023</last_update_submitted>
  <last_update_submitted_qc>February 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anaesthesia</keyword>
  <keyword>Intensive Care</keyword>
  <keyword>vasopressor</keyword>
  <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/NCT03805230
org study id: SQUEEZE
nct id: NCT03805230
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective multi-centre international observational study of postoperative vasopressor
      use, designed to answer the question: 'What is the proportion of patients that receive
      vasopressor infusions? In the management of these patients;

        -  Are there variations in the practice between clinicians, hospitals or countries? If yes,
           are they associated with clinical outcome?

        -  What are the health economic impacts associated with receiving vasopressors?
Postoperative hypotension is a common occurrence following major non-cardiac surgery and the
      use of vasopressors in the postoperative period to support blood pressure following
      optimisation of fluid status is commonplace. Receipt of infused vasopressors postoperatively
      is considered as a surrogate indicator of significant vasodilation. However, the incidence of
      postoperative vasopressor therapy has never been described.

      By contrast to septic shock, there is no uniform definition of postoperative vasoplegia.
      Receipt of any amount of vasopressor would provide an objective dichotomous definition but a
      limitation would be the inability to differentiate degrees of vasodilation. Use of a
      threshold dose of infused vasopressor to determine a definition is uncomfortably arbitrary.
      There have been trials of different vasopressors to treat postoperative vasoplegia in cardiac
      surgical patients and we intend to gather data to inform future design in noncardiac surgery.

      In addition, there is evidence of substantial variation in the management of postoperative
      hypotension between centres, countries and continents. The variation is in assessment
      (cardiac output and invasive monitoring) and environment (post-operative care units,
      high-dependency units, ICUs) and management (use and choice of fluids and
      vasopressors/inotropes). We hypothesise that there is also variation in the incidence of
      organ dysfunction and the use of organ support, and in clinical outcomes including duration
      of stay and mortality.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of postoperative vasopressor usage in a none cardiac surgical population.
time frame: A the primary endpoint is the proportion of patients receiving vasopressor infusions that start between 1 and 24 hours postoperatively
description: 1. What proportions of patients receive infused vasopressors postoperatively?
arm group label: Cohort A
description: all patients admitted to participating hospitals during 7 consecutive days
arm group label: Cohort B
description: 30 sequential patients with a single additional inclusion criterion
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ib Jammer, Dr
role: Study Chair
affiliation: Haukeland University Hospital
last name: Ben Creagh-Brown
role: Study Chair
affiliation: Royal Surrey County Hospital NHS Foundation Trust
last name: Sylvia Daamen
phone: 003222109414
email: research@esaic.org
last name: Pierre Harlet
phone: 3222105773
email: research@esaic.org
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
country: Germany
country: Netherlands
url: https://www.esaic.org/research/clinical-trial-network/squeeze/
description: ESAIC Clinical Trial Network website
citation: Moonesinghe SR, Wong DJN, Farmer L, Shawyer R, Myles PS, Harris SK; SNAP-2 Project team and Steering Group. SNAP-2 EPICCS: the second Sprint National Anaesthesia Project-EPIdemiology of Critical Care after Surgery: protocol for an international observational cohort study. BMJ Open. 2017 Sep 7;7(9):e017690. doi: 10.1136/bmjopen-2017-017690.
PMID: 28882925
citation: Global patient outcomes after elective surgery: prospective cohort study in 27 low-, middle- and high-income countries. Br J Anaesth. 2017 Sep 1;119(3):553. doi: 10.1093/bja/aew472. No abstract available.
PMID: 28498884
citation: Kho ME, Duffett M, Willison DJ, Cook DJ, Brouwers MC. Written informed consent and selection bias in observational studies using medical records: systematic review. BMJ. 2009 Mar 12;338:b866. doi: 10.1136/bmj.b866.
PMID: 19282440
citation: Biccard BM, Madiba TE, Kluyts HL, Munlemvo DM, Madzimbamuto FD, Basenero A, Gordon CS, Youssouf C, Rakotoarison SR, Gobin V, Samateh AL, Sani CM, Omigbodun AO, Amanor-Boadu SD, Tumukunde JT, Esterhuizen TM, Manach YL, Forget P, Elkhogia AM, Mehyaoui RM, Zoumeno E, Ndayisaba G, Ndasi H, Ndonga AKN, Ngumi ZWW, Patel UP, Ashebir DZ, Antwi-Kusi AAK, Mbwele B, Sama HD, Elfiky M, Fawzy MA, Pearse RM; African Surgical Outcomes Study (ASOS) investigators. Perioperative patient outcomes in the African Surgical Outcomes Study: a 7-day prospective observational cohort study. Lancet. 2018 Apr 21;391(10130):1589-1598. doi: 10.1016/S0140-6736(18)30001-1. Epub 2018 Jan 3.
PMID: 29306587
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: Lambden S, Creagh-Brown BC, Hunt J, Summers C, Forni LG. Definitions and pathophysiology of vasoplegic shock. Crit Care. 2018 Jul 6;22(1):174. doi: 10.1186/s13054-018-2102-1.
PMID: 29980217
citation: Hajjar LA, Vincent JL, Barbosa Gomes Galas FR, Rhodes A, Landoni G, Osawa EA, Melo RR, Sundin MR, Grande SM, Gaiotto FA, Pomerantzeff PM, Dallan LO, Franco RA, Nakamura RE, Lisboa LA, de Almeida JP, Gerent AM, Souza DH, Gaiane MA, Fukushima JT, Park CL, Zambolim C, Rocha Ferreira GS, Strabelli TM, Fernandes FL, Camara L, Zeferino S, Santos VG, Piccioni MA, Jatene FB, Costa Auler JO Jr, Filho RK. Vasopressin versus Norepinephrine in Patients with Vasoplegic Shock after Cardiac Surgery: The VANCS Randomized Controlled Trial. Anesthesiology. 2017 Jan;126(1):85-93. doi: 10.1097/ALN.0000000000001434.
PMID: 27841822
citation: Abbott TEF, Fowler AJ, Pelosi P, Gama de Abreu M, Moller AM, Canet J, Creagh-Brown B, Mythen M, Gin T, Lalu MM, Futier E, Grocott MP, Schultz MJ, Pearse RM; StEP-COMPAC Group. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications. Br J Anaesth. 2018 May;120(5):1066-1079. doi: 10.1016/j.bja.2018.02.007. Epub 2018 Mar 27.
PMID: 29661384
citation: Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.
PMID: 25058504
responsible party type: Sponsor
sharing ipd: No