Clinical trial NCT03777150: Is There a Benefit of Postoperative ICU Management After Elective Surgery in Critical Ill Patients?
Official title: Is There a Benefit of Postoperative ICU Management After Elective Surgery in Terms of Patient's Outcome, Length of Hospital Stay, Complications and Cost?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Care
Intensive Care
Keywords: Intensive care
postoperative care
elective surgery
Lead sponsor: Saint Savvas Anticancer Hospital
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group I: admitted into the ICU for postoperative care Group II: admitted into a standard ward for postoperative care
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total length of hospital stay
timeFrame: 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
Secondary outcomes:
measure: Preoperative length of hospital stay
timeFrame: 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
measure: Postoperative length of hospital stay
timeFrame: 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
measure: Postoperative complications
timeFrame: 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
measure: Patient's outcome at 28 days postoperatively
timeFrame: From the first postoperative day until 28 days postoperatively
measure: Total cost of hospital care
timeFrame: 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
measure: Postoperative cost of hospital care
timeFrame: 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
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Saint Savvas Anticancer Hospital of Athens
Study officials:
affiliation: Saint Savvas Anticancer hospital of Athens
name: Anna Efthimiou, Head of the department
role: STUDY_DIRECTOR
References: