Clinical trial NCT05474872: Postoperative Delirium in the ICU Setting of an Eastern European Centre
Official title: Postoperative Delirium: a Complex Prediction Model in Patients Undergoing Major Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Delirium
Cognitive Impairment
Keywords: postoperative delirium
abdominal surgery
malondialdehyde
S100B protein
Tau protein
pNF-H
Bispectral Index
anesthesia depth
general anesthesia
Lead sponsor: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Prediction model for postoperative delirium (POD) in major abdominal surgery
timeFrame: 3-4 years
Secondary outcomes:
measure: Anesthesia depth monitoring and the incidence of postoperative delirium
timeFrame: 0-4 days postoperatively
measure: Postoperative delirium incidence in surgical patients in the Intensive Care Unit (ICU) setting
timeFrame: during ICU hospitalization
measure: Postoperative delirium incidence in surgical patients - subgroup - communism survivors
timeFrame: during ICU hospitalization
measure: Postoperative delirium incidence in surgical patients - subgroup - patients with no relatives/visitors
timeFrame: during ICU hospitalization
Other outcomes:
measure: The influence of POD on length of stay (LOS), unplanned ICU re-admission, cognitive decline and mortality
timeFrame: during patient hospitalization
Locations:
city: Cluj-Napoca
country: Romania
facility: Regional Institute of Gastroenterology and Hepatology "Prof.Dr.O.Fodor"
state: Cluj
Study officials:
affiliation: Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor
name: Daniela Ionescu, MD, PhD
role: STUDY_DIRECTOR
affiliation: Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor
name: Mara Mihaescu, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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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.
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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.