Is There a Benefit of Postoperative ICU Management After Elective Surgery in Critical Ill Patients?

NCT03777150 — Not applicable, Unknown, 150 participants, Saint Savvas Anticancer Hospital

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Is There a Benefit of Postoperative ICU Management After Elective Surgery in Terms of Patient's Outcome, Length of Hospital Stay, Complications and Cost?

Registry	NCT03777150
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	150 (Estimated)
Sponsor	Saint Savvas Anticancer Hospital (Other)
Conditions	Postoperative Care, Intensive Care
Interventions	Postoperative care in Intensive care unit (ICU), Postoperative care in standard ward (Other)
Dates	start 2018-10-10, primary completion 2020-12-01 (estimated), completion 2021-06-01 (estimated), first posted 2018-12-17, last updated 2018-12-17
Locations	1 site in Greece

-Summary

Postoperative care of high risk patients in the Intensive Care Unit (ICU) has for long been considered to be the gold standard of care in terms of reducing perioperative mortality.New evidence from a 7-day cohort study involving 27 countries comes to question this practice. The primary objective of our study is to detect any benefit of postoperative ICU care after elective surgery in terms of patient's outcome, length of hospital stay, complications and cost.

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+Detailed description

A prospective analysis of high perioperative risk patients that are about to be subjected into an elective operation will be included into the study. They will be allocated into two groups. Group ICU patients are those that are admitted into the ICU for postoperative care and those that are admitted into a standard ward consist Group Ward. Demographic data, the length of hospital stay, the outcome, the need of mechanical ventilation, the complications and the total cost will be recorded.

+Arms and interventions

Arm	Type	Interventions	Description
Group ICU	Experimental	Other: Postoperative care in Intensive care unit (ICU)	Group ICU:patients are admitted directly into the ICU for postoperative care
Group Ward	Experimental	Other: Postoperative care in standard ward	Group Ward:patients are admitted directly into the standard ward for postoperative care

Postoperative care in Intensive care unit (ICU) (Other): Postoperative care in Intensive care unit (ICU)
Postoperative care in standard ward (Other): Postoperative care in standard ward

+Outcome measures

Primary outcomes

Total length of hospital stay [From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months]: The total length of patient's hospital stay will be recorded

Secondary outcomes

Preoperative length of hospital stay [From date of hospital admission until the date of operation or date of death from any cause, whichever came first, assessed up to 6 months]: The preoperative length of patient's hospital stay will be recorded
Postoperative length of hospital stay [From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months]: The postoperative length of patient's hospital stay will be recorded
Postoperative complications [From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months]: All postoperative complications will be recorded
Patient's outcome at 28 days postoperatively [From the first postoperative day until 28 days postoperatively]: 28 day postoperative mortality will be recorded
Total cost of hospital care [From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months]: The total cost of hospital care will be recorded for every patient
Postoperative cost of hospital care [From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months]: The postoperative cost of hospital care will be recorded for every patient

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* All patients that will be scheduled for an elective operation and are considered to be in a high perioperative risk

Exclusion Criteria:

* Patients that are operated on an emergency basis

+Locations (1)

Facility	City	Country	Status
Saint Savvas Anticancer Hospital of Athens	Athens	Greece	Recruiting

+Investigators

Anna Efthimiou, Head of the department, Study director, Saint Savvas Anticancer hospital of Athens