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

Sponsor
Saint Savvas Anticancer Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03777150
Collaborator
(none)
150
1
2
31.7
4.7

Study Details

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

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
Anticipated 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 careGroup 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 :
Oct 10, 2018
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Jun 1, 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 [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 [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 [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 [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 [From the first postoperative day until 28 days postoperatively]

    28 day postoperative mortality will be recorded

  5. 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

  6. 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 Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Saint Savvas Anticancer Hospital of Athens Athens Greece

Sponsors and Collaborators

  • Saint Savvas Anticancer Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Dec 17, 2018
Last Update Posted:
Dec 17, 2018
Last Verified:
Dec 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
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, Anesthesiologist,MD, PhD Principal Investigator, Saint Savvas Anticancer Hospital

Study Results

No Results Posted as of Dec 17, 2018