Postoperative Delirium in the ICU Setting of an Eastern European Centre

NCT05474872 | Unknown

• 1 other identifier: 456/12.01.2022
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium; Cognitive Impairment

Keywords

postoperative delirium; abdominal surgery; malondialdehyde; S100B protein; Tau protein; pNF-H; Bispectral Index; anesthesia depth; general anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

Other Outcomes (1)

• The influence of POD on length of stay (LOS), unplanned ICU re-admission, cognitive decline and mortality

  during patient hospitalization

Study Arms (2)

BIS monitoring

Patients in this group will be subjected to Bispectral index-guided general anesthesia.

Device: BIS monitoring

PRST score monitoring

Patients in this group will be subjected PRST score-guided general anesthesia.

Interventions

BIS monitoring DEVICE

The depth of anesthesia will be monitored using Bispectral Index values.

BIS monitoring

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor: lead

Study Sites (1)

Regional Institute of Gastroenterology and Hepatology "Prof.Dr.O.Fodor"

Cluj-Napoca, Cluj, 400162, Romania

RECRUITING

Related Publications (8)

• 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.

  PMID: 31881996 BACKGROUND

• 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.

  PMID: 31166241 BACKGROUND

• 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.

  PMID: 31897646 BACKGROUND

• 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.

  PMID: 28608014 BACKGROUND

• 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.

  PMID: 29656802 BACKGROUND

• 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.

  PMID: 28504118 BACKGROUND

• 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.

  PMID: 30348620 BACKGROUND

• 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.

  PMID: 34465469 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood collected for serum analysis of biomarkers

MeSH Terms

Conditions

Emergence Delirium; Cognitive Dysfunction; Frontotemporal Dementia

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Daniela Ionescu, MD, PhD

  Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor

  STUDY DIRECTOR

• Mara Mihaescu, PhD student

  Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mara Mihaescu, PhD student

CONTACT

+ 40 747540266; mara.mihaescu05@gmail.com

Daniela Ionescu, MD,PhD

CONTACT

dionescuati@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD Student

Study Record Dates

• First Submitted: July 23, 2022
• First Posted: July 26, 2022
• Study Start: July 15, 2022
• Primary Completion: July 30, 2025
• Study Completion: January 31, 2026
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)