Postoperative Delirium in the ICU Setting of an Eastern European Centre

January 7, 2024 updated by: Mara Sonia Mihaescu, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Postoperative Delirium: a Complex Prediction Model in Patients Undergoing Major Abdominal Surgery

The study targets postoperative delirium in patients undergoing major abdominal surgery, with the aim to evaluate the functional baseline and proteomics implicated in pathogenesis, prevention strategies (such as anesthesia depth monitoring) and incidence in certain population groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

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

Study Contact Backup

Study Locations

  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400162
        • Recruiting
        • Regional Institute of Gastroenterology and Hepatology "Prof.Dr.O.Fodor"
        • Contact:

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients aged 18 to 70 years, given informed consent, who will be subjected to major abdominal surgery and admitted in the ICU postoperatively, will be assessed from the preoperative period until hospital discharge, to collect the requisite information.

Description

Inclusion Criteria:

  • ASA risk I-III;
  • patients undergoing complex digestive surgery, such as esophagectomy, total gastrectomy, hemicolectomy, cephalic duodenopancreatectomy, hepatic resection.

Exclusion Criteria:

  • the impossibility of obtaining the patient's consent/his decisional incapacity;
  • patients who underwent neurosurgery for cerebrospinal lesions / cardiac surgery under cardiopulmonary bypass;
  • prediagnosed senile/vascular/mixed dementia.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BIS monitoring
Patients in this group will be subjected to Bispectral index-guided general anesthesia.
Device: BIS monitoring
The depth of anesthesia will be monitored using Bispectral Index values.
PRST score monitoring
Patients in this group will be subjected PRST score-guided general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction model for postoperative delirium (POD) in major abdominal surgery
Time Frame: 3-4 years

Developing an accesible algorithm to anticipate the occurence of postoperative delirium, based on functional baseline and proteomics, in adult patients subjected to major abdominal surgical interventions.

This includes investigating a correlation between a set of risk factors, a panel of biomarkers and the occurrence of postoperative delirium in the enrolled patients, respectively.
3-4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anesthesia depth monitoring and the incidence of postoperative delirium
Time Frame: 0-4 days postoperatively
Assessing the influence of BIS monitoring during general anesthesia on the prevalence of postoperative delirium
0-4 days postoperatively
Postoperative delirium incidence in surgical patients in the Intensive Care Unit (ICU) setting
Time Frame: during ICU hospitalization
during ICU hospitalization
Postoperative delirium incidence in surgical patients - subgroup - communism survivors
Time Frame: during ICU hospitalization
during ICU hospitalization
Postoperative delirium incidence in surgical patients - subgroup - patients with no relatives/visitors
Time Frame: during ICU hospitalization
during ICU hospitalization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The influence of POD on length of stay (LOS), unplanned ICU re-admission, cognitive decline and mortality
Time Frame: during patient hospitalization
Evaluating the possibility of a correlation between the occurence of POD and prolonged hospitalization, a prerequisite for ICU re-admittance or further cognitive deterioration / mortality.
during patient hospitalization

Collaborators and Investigators

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

Sponsor

Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Investigators

  • Study Director: Daniela Ionescu, MD, PhD, Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor
  • Principal Investigator: Mara Mihaescu, PhD student, Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 15, 2022

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

July 23, 2022

First Submitted That Met QC Criteria

July 23, 2022

First Posted (Actual)

July 26, 2022

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 7, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 456/12.01.2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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