Evaluating postoperative delirium in ICU patients after major abdominal surgery
Postoperative Delirium: a Complex Prediction Model in Patients Undergoing Major Abdominal Surgery
This study looks at patients who have major abdominal surgery to see how often they experience confusion afterward and what factors might contribute to it, while also testing ways to help prevent this issue.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor Academic / other |
| Locations | 1 site (Cluj-Napoca, Cluj) |
| Trial ID | NCT05474872 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients undergoing major abdominal surgeries to assess the incidence of postoperative delirium and its associated factors. It aims to evaluate baseline functional status and the role of specific proteins in the pathogenesis of delirium. Additionally, the study will explore prevention strategies, including monitoring anesthesia depth, to mitigate the risk of cognitive impairment in this patient population. The research is conducted at a specialized gastroenterology and hepatology institute in Eastern Europe.
Who should consider this trial
Good fit: Ideal candidates include patients classified as ASA risk I-III who are scheduled for complex digestive surgeries.
Not a fit: Patients who are unable to provide consent, have undergone neurosurgery or cardiac surgery, or have pre-existing dementia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing postoperative delirium, enhancing recovery and cognitive outcomes for patients after major surgery.
How similar studies have performed: While there have been studies on postoperative delirium, this specific approach focusing on proteomics and anesthesia monitoring in this population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cluj-Napoca, Cluj
- Regional Institute of Gastroenterology and Hepatology "Prof.Dr.O.Fodor" — Cluj-Napoca, Cluj, Romania (Recruiting)
Study contacts
- Principal investigator: Mara Mihaescu, PhD student — Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor
- Study coordinator: Mara Mihaescu, PhD student
- Email: mara.mihaescu05@gmail.com
- Phone: + 40 747540266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.