Medtronic Signia SDR Product Surveillance Registry
NCT05095935
Minimally Invasive Surgical Procedures, Surgical Procedures, Operative
Los Angeles, California, United States
View Trial DetailsNCT Number: NCT03805230
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?
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Notify Me18 year and older
All sexes
Observational
University Hospital Knappschaftskrankenhaus Bochum, Bochum, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For Cohort B - One additional inclusion criterion:
Time frame: A the primary endpoint is the proportion of patients receiving vasopressor infusions that start between 1 and 24 hours postoperatively
European Society of Anaesthesiology
Other
Postoperative Vasopressor Usage : a Prospective International Observational Study (SQUEEZE)
Acronym: SQUEEZE
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