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

NCT03777150 | Unknown DMC

• 1 other identifier: ICU postoperative care
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Care; Intensive Care

Keywords

Intensive care; postoperative care; elective surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

• 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

• Patient's outcome at 28 days postoperatively

  From the first postoperative day until 28 days postoperatively

• 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

Study Arms (2)

Group ICU

EXPERIMENTAL

Group ICU:patients are admitted directly into the ICU for postoperative care

Other: Postoperative care in Intensive care unit (ICU)

Group Ward

EXPERIMENTAL

Group Ward:patients are admitted directly into the standard ward for postoperative care

Other: Postoperative care in standard ward

Interventions

Postoperative care in Intensive care unit (ICU) OTHER

Postoperative care in Intensive care unit (ICU)

Group ICU

Postoperative care in standard ward OTHER

Postoperative care in standard ward

Group Ward

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients that will be scheduled for an elective operation and are considered to be in a high perioperative risk

You may not qualify if:

• Patients that are operated on an emergency basis

Sponsors & Collaborators

• Saint Savvas Anticancer Hospital: lead

Study Sites (1)

Saint Savvas Anticancer Hospital of Athens

Athens, Greece

RECRUITING

MeSH Terms

Interventions

Postoperative Care; Intensive Care Units

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Health Services; Health Care Facilities Workforce and Services; Hospital Units; Health Facilities

Study Officials

• Anna Efthimiou, Head of the department

  Saint Savvas Anticancer hospital of Athens

  STUDY DIRECTOR

Central Study Contacts

Georgia Micha, MD, PhD

CONTACT

6974828254; mgeo3@yahoo.gr

Vasiliki Chantziara, MD, PHD

CONTACT

6937173376; vchantziara@yahoo.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist,MD, PhD Principal Investigator

Model Details: Group I: admitted into the ICU for postoperative care Group II: admitted into a standard ward for postoperative care

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 17, 2018
• Study Start: October 10, 2018
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: December 17, 2018

Record last verified: 2018-12

Locations

GR (1)