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Postoperative Vasopressor Usage: SQUEEZE

Sponsor
European Society of Anaesthesiology (Other)
Overall Status
Recruiting
CT.gov ID
NCT03805230
Collaborator
(none)
40,000
Enrollment
2
Locations
30.8
Anticipated Duration (Months)
20000
Patients Per Site
649.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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?

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Postoperative Vasopressor Usage : a Prospective International Observational Study (SQUEEZE)
    Actual Study Start Date :
    Oct 5, 2020
    Anticipated Primary Completion Date :
    Oct 30, 2022
    Anticipated Study Completion Date :
    Apr 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort A

    all patients admitted to participating hospitals during 7 consecutive days
    Cohort B

    30 sequential patients with a single additional inclusion criterion

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of postoperative vasopressor usage in a none cardiac surgical population. [A the primary endpoint is the proportion of patients receiving vasopressor infusions that start between 1 and 24 hours postoperatively]

      1. What proportions of patients receive infused vasopressors postoperatively?

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Undergoing surgery (may be planned or unplanned)

    • No plans for return home on the day of surgery, for medical reasons

    • Age ≥ 18 on day of surgery

    Exclusion Criteria:

    • Cardiac surgery

    • Obstetric surgery

    • Transplant surgery

    • Receiving long-term infusions of vasoactive drugs, such as epoprostenol

    • Mechanical circulatory support: ventricular assist device, intra-aortic balloon pump, artificial heart or similar

    • Already been enrolled in Squeeze

    For Cohort B - One additional inclusion criterion:
    • Receiving infusion of vasopressors that continues after the patient has left the operating room.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Knappschaftskrankenhaus Bochum Bochum Germany
    2 Wilhelmina Hospital Assen Assen Netherlands

    Sponsors and Collaborators

    • European Society of Anaesthesiology

    Investigators

    • Study Chair: Ib Jammer, Dr, Haukeland University Hospital
    • Study Chair: Ben Creagh-Brown, Royal Surrey County Hospital NHS Foundation Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    European Society of Anaesthesiology
    ClinicalTrials.gov Identifier:
    NCT03805230
    Other Study ID Numbers:
    • SQUEEZE
    First Posted:
    Jan 15, 2019
    Last Update Posted:
    Feb 15, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by European Society of Anaesthesiology
    anaesthesia
    Intensive Care
    vasopressor

    Study Results

    No Results Posted as of Feb 15, 2022