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Postoperative DeliriumNCT05474872

Postoperative Delirium in the ICU Setting of an Eastern European Centre

An observational study of Postoperative Delirium and Cognitive Impairment, run by Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor at 1 site in Romania.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Postoperative Delirium, Cognitive Impairment
What is being tested?
BIS monitoring
Type of treatment
Medical device
How many people
100 participants
Where
1 siteRomania
Study dates
15 Jul 2022to 31 Jan 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Mara Mihaescu, PhD student contact

+ 40 747540266

mara.mihaescu05@gmail.com

Daniela Ionescu, MD,PhD contact

dionescuati@yahoo.com

Romania1 site, 1 recruiting

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

    Cluj-Napoca, Cluj, 400162

    Mara Mihaescu, PhD student, + 40 747540266, mara.mihaescu05@gmail.com

    Recruiting

Other trials in Romania

About this study

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

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.

Being tested
BIS monitoring
Keywords
postoperative delirium, abdominal surgery, malondialdehyde, S100B protein, Tau protein, pNF-H, Bispectral Index, anesthesia depth, general anesthesia
Medical subject headings
Emergence Delirium, Cognitive Dysfunction, Frontotemporal Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIS monitoringDevice

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

Study groups in NCT05474872
Study groupRoleWhat they receive
BIS monitoringPatients in this group will be subjected to Bispectral index-guided general anesthesia.
Receives: Device: BIS monitoring
PRST score monitoringPatients in this group will be subjected PRST score-guided general anesthesia.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3-4 years

Secondary outcomes (4)

  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

    Measured: 0-4 days postoperatively

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

    Measured: during ICU hospitalization

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

    Measured: during ICU hospitalization

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

    Measured: during ICU hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2022
  2. Study start15 Jul 2022
  3. Primary completion30 Jul 2025 (estimated)
  4. Study completion31 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05474872
Sponsor's protocol ID
456/12.01.2022
Status last verified
Jan 2024
First submitted
23 Jul 2022
Last updated
9 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Delirium and Cognitive Impairment, run by Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor at 1 site in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mara Mihaescu, PhD student (+ 40 747540266, mara.mihaescu05@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prediction model for postoperative delirium (POD) in major abdominal surgery (time frame: 3-4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05474872, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.

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