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Clinical Trials/NCT05474872
NCT05474872
Recruiting
Not Applicable

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

Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor1 site in 1 country100 target enrollmentJuly 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Delirium
Sponsor
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Enrollment
100
Locations
1
Primary Endpoint
Prediction model for postoperative delirium (POD) in major abdominal surgery
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2022
End Date
January 31, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Responsible Party
Principal Investigator
Principal Investigator

Mara Sonia Mihaescu

Principal Investigator, PhD Student

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

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Postoperative delirium incidence in surgical patients - subgroup - communism survivors(during ICU hospitalization)
  • Postoperative delirium incidence in surgical patients - subgroup - patients with no relatives/visitors(during ICU hospitalization)
  • Anesthesia depth monitoring and the incidence of postoperative delirium(0-4 days postoperatively)
  • Postoperative delirium incidence in surgical patients in the Intensive Care Unit (ICU) setting(during ICU hospitalization)

Study Sites (1)

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