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

• ClinicalTrials.gov Identifier: NCT03777150
• Recruitment Status: Unknown
• First Posted: December 17, 2018
• Last Update Posted: December 17, 2018
• Sponsor: Saint Savvas Anticancer Hospital
• Information provided by (Responsible Party): Georgia Micha, Saint Savvas Anticancer Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Care; Intensive Care	Other: Postoperative care in Intensive care unit (ICU); Other: Postoperative care in standard ward	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Group I: admitted into the ICU for postoperative care Group II: admitted into a standard ward for postoperative care
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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?
• Actual Study Start Date: October 10, 2018
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: June 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group ICU; Group ICU:patients are admitted directly into the ICU for postoperative care	Other: Postoperative care in Intensive care unit (ICU); Postoperative care in Intensive care unit (ICU)
Experimental: Group Ward; Group Ward:patients are admitted directly into the standard ward for postoperative care	Other: Postoperative care in standard ward; Postoperative care in standard ward

Outcome Measures

Primary Outcome Measures :

1. Total length of hospital stay [ Time Frame: 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 Outcome Measures :

1. Preoperative length of hospital stay [ Time Frame: 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
2. Postoperative length of hospital stay [ Time Frame: 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
3. Postoperative complications [ Time Frame: 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
4. Patient's outcome at 28 days postoperatively [ Time Frame: From the first postoperative day until 28 days postoperatively ]
   28 day postoperative mortality will be recorded
5. Total cost of hospital care [ Time Frame: 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
6. Postoperative cost of hospital care [ Time Frame: 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 Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Georgia Micha, MD, PhD; 6974828254 ext 0030; mgeo3@yahoo.gr

Contact: Vasiliki Chantziara, MD, PHD; 6937173376 ext 0030; vchantziara@yahoo.gr

Locations

Greece

Saint Savvas Anticancer Hospital of Athens; Recruiting

Athens, Greece

Contact: Georgia Micha, MD, MSc, PhD +306974828254

Sponsors and Collaborators

Saint Savvas Anticancer Hospital

Investigators

• Study Director: Anna Efthimiou, Head of the department; Saint Savvas Anticancer hospital of Athens

More Information

• Responsible Party: Georgia Micha, Anesthesiologist,MD, PhD Principal Investigator, Saint Savvas Anticancer Hospital
• ClinicalTrials.gov Identifier: NCT03777150
• Other Study ID Numbers: ICU postoperative care
• First Posted: December 17, 2018
• Last Update Posted: December 17, 2018
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Georgia Micha, Saint Savvas Anticancer Hospital:

Intensive care; postoperative care; elective surgery