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

December 14, 2018 updated by: Georgia Micha, Saint Savvas Anticancer Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Georgia Micha, MD, PhD
  • Phone Number: 0030 6974828254
  • Email: mgeo3@yahoo.gr

Study Contact Backup

Study Locations

  • Greece
      • Athens, Greece
        • Recruiting
        • Saint Savvas Anticancer Hospital of Athens
        • Contact:
          • Georgia Micha, MD, MSc, PhD
          • Phone Number: +306974828254

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
From the first postoperative day until 28 days postoperatively
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Savvas Anticancer Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2018

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

December 10, 2018

First Submitted That Met QC Criteria

December 14, 2018

First Posted (Actual)

December 17, 2018

Study Record Updates

Last Update Posted (Actual)

December 17, 2018

Last Update Submitted That Met QC Criteria

December 14, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ICU postoperative care

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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