Postoperative Vasopressor Usage: SQUEEZE (SQUEEZE)

April 9, 2024 updated by: European Society of Anaesthesiology

Postoperative Vasopressor Usage : a Prospective International Observational Study (SQUEEZE)

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?

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

25000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bochum, Germany
        • University Hospital Knappschaftskrankenhaus Bochum
  • Netherlands
      • Assen, Netherlands
        • Wilhelmina Hospital Assen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult Patients undergoing any non-cardiac surgical procedure.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort A
all patients admitted to participating hospitals during 7 consecutive days
Cohort B
30 sequential patients with a single additional inclusion criterion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1. What proportions of patients receive infused vasopressors postoperatively?
A the primary endpoint is the proportion of patients receiving vasopressor infusions that start between 1 and 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2020

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

January 14, 2019

First Posted (Actual)

January 15, 2019

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SQUEEZE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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