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

Intensive Care Clinical Trial

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03777150
• Other study ID #: ICU postoperative care
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: June 2021

Study information

• Verified date: December 2018
• Source: Saint Savvas Anticancer Hospital
• Contact: Georgia Micha, MD, PhD
• Phone: 6974828254
• Email: mgeo3[@]yahoo.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care
• Postoperative Care

Intervention

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

Locations

Country	Name	City	State
Greece	Saint Savvas Anticancer Hospital of Athens	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Saint Savvas Anticancer Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total length of hospital stay	The total length of patient's hospital stay will be recorded	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	Preoperative length of hospital stay	The preoperative length of patient's hospital stay will be recorded	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
Secondary	Postoperative length of hospital stay	The postoperative length of patient's hospital stay will be recorded	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
Secondary	Postoperative complications	All postoperative complications will be recorded	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
Secondary	Patient's outcome at 28 days postoperatively	28 day postoperative mortality will be recorded	From the first postoperative day until 28 days postoperatively
Secondary	Total cost of hospital care	The total cost of hospital care will be recorded for every patient	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	Postoperative cost of hospital care	The postoperative cost of hospital care will be recorded for every patient	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