Postoperative Vasopressor Usage: SQUEEZE

NCT ID: NCT03805230

Last Updated: 2024-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-05

Study Completion Date

2024-03-31

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Surgical Procedures, Operative Vasopressor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A

all patients admitted to participating hospitals during 7 consecutive days

No interventions assigned to this group

Cohort B

30 sequential patients with a single additional inclusion criterion

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Society of Anaesthesiology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ib Jammer, Dr

Role: STUDY_CHAIR

Haukeland University Hospital

Ben Creagh-Brown

Role: STUDY_CHAIR

Royal Surrey County Hospital NHS Foundation Trust

Locations

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University Hospital Knappschaftskrankenhaus Bochum

Bochum, , Germany

Site Status

Wilhelmina Hospital Assen

Assen, , Netherlands

Site Status

Countries

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Germany Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 28882925 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28498884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19282440 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29306587 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22998715 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29980217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27841822 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29661384 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25058504 (View on PubMed)

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 Aug 11:S0007-0912(25)00450-7. doi: 10.1016/j.bja.2025.07.034. Online ahead of print.

Reference Type DERIVED
PMID: 40796492 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36964590 (View on PubMed)

Related Links

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https://esaic.org/study/squeeze-study/

ESAIC Clinical Trial Network website

Other Identifiers

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SQUEEZE

Identifier Type: -

Identifier Source: org_study_id

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