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RecruitingNCT05474872Updated Jan 9, 2024

Postoperative Delirium in the ICU Setting of an Eastern European Centre

An observational study in Postoperative Delirium and Cognitive Impairment, sponsored by Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor. Recruiting at 1 site in Romania. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-01-09.

Sponsored by Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Jul 2022; still recruiting 4 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Postoperative Delirium
  • Cognitive Impairment

Keywords

  • postoperative delirium
  • abdominal surgery
  • malondialdehyde
  • S100B protein
  • Tau protein
  • pNF-H
  • Bispectral Index
  • anesthesia depth
  • general anesthesia
03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 418 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • DeviceBIS monitoring

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

06

What researchers measure

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.

    Time frame: 3-4 years

Secondary outcomes

  1. Anesthesia depth monitoring and the incidence of postoperative delirium

    Assessing the influence of BIS monitoring during general anesthesia on the prevalence of postoperative delirium

    Time frame: 0-4 days postoperatively

  2. Postoperative delirium incidence in surgical patients in the Intensive Care Unit (ICU) setting

    Time frame: during ICU hospitalization

  3. Postoperative delirium incidence in surgical patients - subgroup - communism survivors

    Time frame: during ICU hospitalization

  4. Postoperative delirium incidence in surgical patients - subgroup - patients with no relatives/visitors

    Time frame: during ICU hospitalization

Other outcomes

  1. 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.

    Time frame: during patient hospitalization

07

Study locations

1 of 1 sites recruiting
  • Regional Institute of Gastroenterology and Hepatology "Prof.Dr.O.Fodor"
    Cluj-Napoca, Cluj 400162, Romania
    Recruiting
08

References and documents

Publications

  • 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. PubMed 31881996 ↗
  • 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. PubMed 31166241 ↗
  • 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. PubMed 31897646 ↗
  • 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. PubMed 28608014 ↗
  • 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. PubMed 29656802 ↗
  • 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. PubMed 28504118 ↗
  • 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. PubMed 30348620 ↗
  • 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. PubMed 34465469 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05474872
Lead sponsor
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Responsible party
Mara Sonia Mihaescu (Principal Investigator, PhD Student, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor) — Principal investigator
First posted
Jul 26, 2022
Start date
Jul 15, 2022
Primary completion
Jul 30, 2025 (estimated)
Completion
Jan 31, 2026 (estimated)
Last update
Jan 9, 2024

Study contacts

Mara Mihaescu, PhD student
Contact
mara.mihaescu05@gmail.com
+ 40 747540266
Daniela Ionescu, MD,PhD
Contact
dionescuati@yahoo.com
Daniela Ionescu, MD, PhD
study director · Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor
Mara Mihaescu, PhD student
principal investigator · Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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