Postoperative Delirium in the ICU Setting of an Eastern European Centre

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05474872
• Other study ID #: 456/12.01.2022
• Status: Recruiting
• Start date: July 15, 2022
• Est. completion date: January 31, 2026

Study information

• Verified date: January 2024
• Source: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
• Contact: Mara Mihaescu, PhD student
• Phone: + 40 747540266
• Email: mara.mihaescu05[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 31, 2026
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Impairment
• Delirium
• Emergence Delirium
• Postoperative Delirium

Intervention

Device:
• BIS monitoring
The depth of anesthesia will be monitored using Bispectral Index values.

Locations

Country	Name	City	State
Romania	Regional Institute of Gastroenterology and Hepatology "Prof.Dr.O.Fodor"	Cluj-Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Country where clinical trial is conducted

Romania, 

References & Publications (8)

Alam A, Hana Z, Jin Z, Suen KC, Ma D. Surgery, neuroinflammation and cognitive impairment. EBioMedicine. 2018 Nov;37:547-556. doi: 10.1016/j.ebiom.2018.10.021. Epub 2018 Oct 19. — View Citation

Belrose JC, Noppens RR. Anesthesiology and cognitive impairment: a narrative review of current clinical literature. BMC Anesthesiol. 2019 Dec 27;19(1):241. doi: 10.1186/s12871-019-0903-7. — View Citation

Daiello LA, Racine AM, Yun Gou R, Marcantonio ER, Xie Z, Kunze LJ, Vlassakov KV, Inouye SK, Jones RN, Alsop D, Travison T, Arnold S, Cooper Z, Dickerson B, Fong T, Metzger E, Pascual-Leone A, Schmitt EM, Shafi M, Cavallari M, Dai W, Dillon ST, McElhaney J, Guttmann C, Hshieh T, Kuchel G, Libermann T, Ngo L, Press D, Saczynski J, Vasunilashorn S, O'Connor M, Kimchi E, Strauss J, Wong B, Belkin M, Ayres D, Callery M, Pomposelli F, Wright J, Schermerhorn M, Abrantes T, Albuquerque A, Bertrand S, Brown A, Callahan A, D'Aquila M, Dowal S, Fox M, Gallagher J, Anna Gersten R, Hodara A, Helfand B, Inloes J, Kettell J, Kuczmarska A, Nee J, Nemeth E, Ochsner L, Palihnich K, Parisi K, Puelle M, Rastegar S, Vella M, Xu G, Bryan M, Guess J, Enghorn D, Gross A, Gou Y, Habtemariam D, Isaza I, Kosar C, Rockett C, Tommet D, Gruen T, Ross M, Tasker K, Gee J, Kolanowski A, Pisani M, de Rooij S, Rogers S, Studenski S, Stern Y, Whittemore A, Gottlieb G, Orav J, Sperling R; SAGES Study Group*. Postoperative Delirium and Postoperative Cognitive Dysfunction: Overlap and Divergence. Anesthesiology. 2019 Sep;131(3):477-491. doi: 10.1097/ALN.0000000000002729. — View Citation

Evered LA, Chan MTV, Han R, Chu MHM, Cheng BP, Scott DA, Pryor KO, Sessler DI, Veselis R, Frampton C, Sumner M, Ayeni A, Myles PS, Campbell D, Leslie K, Short TG. Anaesthetic depth and delirium after major surgery: a randomised clinical trial. Br J Anaesth. 2021 Nov;127(5):704-712. doi: 10.1016/j.bja.2021.07.021. Epub 2021 Aug 28. — View Citation

Inoue R, Sumitani M, Ogata T, Chikuda H, Matsubara T, Kato S, Shimojo N, Uchida K, Yamada Y. Direct evidence of central nervous system axonal damage in patients with postoperative delirium: A preliminary study of pNF-H as a promising serum biomarker. Neurosci Lett. 2017 Jul 13;653:39-44. doi: 10.1016/j.neulet.2017.05.023. Epub 2017 May 11. — View Citation

Lee SH, Lim SW. Risk factors for postoperative delirium after colorectal surgery: a systematic review and meta-analysis. Int J Colorectal Dis. 2020 Mar;35(3):433-444. doi: 10.1007/s00384-019-03498-6. Epub 2020 Jan 2. — View Citation

Park SA, Tomimaru Y, Shibata A, Miyagawa S, Noguchi K, Dono K. Incidence and Risk Factors for Postoperative Delirium in Patients After Hepatectomy. World J Surg. 2017 Nov;41(11):2847-2853. doi: 10.1007/s00268-017-4079-3. — View Citation

Saxena S, Maze M. Impact on the brain of the inflammatory response to surgery. Presse Med. 2018 Apr;47(4 Pt 2):e73-e81. doi: 10.1016/j.lpm.2018.03.011. Epub 2018 Apr 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The influence of POD on length of stay (LOS), unplanned ICU re-admission, cognitive decline and mortality	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
Primary	Prediction model for postoperative delirium (POD) in major abdominal surgery	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	Anesthesia depth monitoring and the incidence of postoperative delirium	Assessing the influence of BIS monitoring during general anesthesia on the prevalence of postoperative delirium	0-4 days postoperatively
Secondary	Postoperative delirium incidence in surgical patients in the Intensive Care Unit (ICU) setting		during ICU hospitalization
Secondary	Postoperative delirium incidence in surgical patients - subgroup - communism survivors		during ICU hospitalization
Secondary	Postoperative delirium incidence in surgical patients - subgroup - patients with no relatives/visitors		during ICU hospitalization