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Surgical Procedures, OperativeSQUEEZENCT03805230

Postoperative Vasopressor Usage: SQUEEZE

An observational study of Surgical Procedures, Operative and Vasopressor, run by European Society of Anaesthesiology at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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?… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgical Procedures, Operative, Vasopressor
How many people
25,000 participants
Where
2 sitesin 2 countries
Study dates
5 Oct 2020to 31 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult Patients undergoing any non-cardiac surgical procedure.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Germany1 site

  • University Hospital Knappschaftskrankenhaus Bochum

    Bochum

Other trials in Germany

Netherlands1 site

  • Wilhelmina Hospital Assen

    Assen

Other trials in Netherlands

About this study

Official title: 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?
Read the 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.

Keywords
anaesthesia, Intensive Care, vasopressor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03805230
Study groupRoleWhat they receive
Cohort Aall patients admitted to participating hospitals during 7 consecutive days
Cohort B30 sequential patients with a single additional inclusion criterion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of postoperative vasopressor usage in a none cardiac surgical population.

    1. What proportions of patients receive infused vasopressors postoperatively?

    Measured: A the primary endpoint is the proportion of patients receiving vasopressor infusions that start between 1 and 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2019
  2. Study start5 Oct 2020
  3. Primary completion1 Oct 2023
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
25,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03805230
Sponsor's protocol ID
SQUEEZE
Acronym
SQUEEZE
Status last verified
Apr 2024
First submitted
14 Jan 2019
Last updated
10 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28882925

  • 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.

    PubMed 28498884

  • 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.

    PubMed 19282440

  • 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.

    PubMed 29306587

  • 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.

    PubMed 22998715

  • 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.

    PubMed 29980217

  • 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.

    PubMed 27841822

  • 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.

    PubMed 29661384

  • 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.

    PubMed 25058504

  • Ripolles-Melchor J, Jammer I, Creagh-Brown B, Monge-Garcia MI, Espinosa AV, Abad-Motos A, Navarro-Perez R, Budithi R, Abad-Gurumeta A, Aldecoa C; Squeeze Investigators. Postoperative Vasoactive Exposure Patterns and Outcomes After Non-Cardiac Surgery: A Prespecified Analysis of the SQUEEZE Cohort. Acta Anaesthesiol Scand. 2026 Nov;70(10):e70355. doi: 10.1111/aas.70355.

    PubMed 42860683

  • Jammer I, Martin P, Wunsch H, Debouche S, Harlet P, Moonesinghe R, Forni L, Creagh-Brown B; Writing committee for the Squeeze investigators. Vasopressor use after noncardiac surgery: an international observational study. Br J Anaesth. 2025 Dec;135(6):1609-1617. doi: 10.1016/j.bja.2025.07.034. Epub 2025 Aug 11.

    PubMed 40796492

  • Creagh-Brown B, Wunsch H, Martin P, Harlet P, Forni L, Moonesinghe SR, Jammer I. The incidence of postoperative vasopressor usage: protocol for a prospective international observational cohort study (SQUEEZE). Perioper Med (Lond). 2023 Mar 24;12(1):8. doi: 10.1186/s13741-023-00296-1.

    PubMed 36964590

Questions about this trial

What is this clinical trial studying?

An observational study of Surgical Procedures, Operative and Vasopressor, run by European Society of Anaesthesiology at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03805230, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.

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