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Cognitive ImpairmentCONFESSNCT03486288

Cognitive Impairment Following Elective Spine Surgery

An observational study of Cognitive Impairment and Postoperative Delirium, run by University Medicine Greifswald at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Older people are a rapidly growing proportion of the world's population and their number is expected to increase twofold by 2050. When these people become patients that require surgery, they are at particular high risk for postoperative delirium (POD), which is associated with longer hospital stays, higher costs, risk… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
How many people
124 participants
Where
1 siteGermany
Study dates
6 Feb 2018to 30 Mar 2021
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: All patients seen in a neurosurgical oupatient clinic will be screened for eligibility.

Who may be able to join

  • age ≥ 60 years
  • scheduled for elective spine surgery without opening the dura
  • patient can give informed consent him-/herself
  • German native speaker

Who cannot join

  • dementia or neurodegenerative disease
  • psychiatric disease
  • prescription of CNS-active medication (e.g. antidepressants, antipsychotics, sedatives, alpha-1-antagonists)
  • impossible to participate in follow-up
  • participation in an interventional trial
  • electronic or displacable metallic implants
  • active neoplasm

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Neurology

    Greifswald, Mecklenburg-Vorpommern, 17475

Other trials in Germany

About this study

Official title: Kognitive Störungen Nach Elektiver Wirbelsäulenchirurgie Bei Älteren

Older people are a rapidly growing proportion of the world's population and their number is expected to increase twofold by 2050. When these people become patients that require surgery, they are at particular high risk for postoperative delirium (POD), which is associated with longer hospital stays, higher costs, risk for delayed complications and cognitive dysfunction (POCD). Having suffered an episode of delirium is furthermore a predictor of long-term care dependency. Despite these risks, an increasing number of elderly undergo major elective surgery. This is reflected by the frequency of elective spinal surgery, in general, and instrumented fusions, in particular, which has markedly increased over the past few decades.

It is yet insufficiently understood, which, particularly modifiable, factors contribute to the development of POD and POCD following these major but plannable surgeries. A better understanding of risk factors would facilitate informed patient decisions and surgical strategies could be tailored to individual risk profiles.

Keywords
delirium, postoperative cognitive dysfunction, spine surgery, elderly, neuroinflammation, magnetic resonance imaging, resting state fmri, cerebral vasculature, quality of life
Medical subject headings
Cognitive Dysfunction, Emergence Delirium, Delirium, Postoperative Cognitive Complications, Neuroinflammatory Diseases

What participants receive

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

Study groups in NCT03486288
Study groupRoleWhat they receive
DeliriumNot described
No DeliriumNot described

What is being measured

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

  1. postoperative delirium - incidence

    screening through Nu-DESC (Nursing Delirium Screening Scale) ≥ 2 and verification of screening procedure by DSM-V (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) criteria once during each shift

    Measured: ≤ 3 days postoperatively

Secondary outcomes (15)

  1. postoperative delirium - duration

    screening through Nu-DESC ≥ 2 and verification of screening procedure by DSM-V criteria DSM-V once during each shift

    Measured: ≤ 3 days postoperatively or until delirium resolves

  2. postoperative delirium - severity

    rated through CAM-S (Confusion Assessment Method - Severity) if patient was identified to be delirious

    Measured: ≤ 3 days postoperatively or until delirium resolves

  3. postoperative cognitive dysfunction - severity

    CERAD-Plus (Consortium to Establish a Registry for Alzheimer's Disease - Plus)

    Measured: baseline and 3 months postoperatively

  4. pre- and postoperative intelligence

    MWT-B (Mehrfachwahl-Wortschatz-Intelligenztest - B)

    Measured: baseline and 3 months postoperatively

  5. Markers of systemic inflammation

    C-reactive protein, Interleukins, Tumor necrosis factor among others

    Measured: ≤ 2 days postoperatively

  6. Markers of neuroinflammation

    Glial fibrillary acidic protein among others

    Measured: ≤ 2 days postoperatively

  7. Markers of oxidative and metabolic stress

    Malondialdehyd

    Measured: ≤ 2 days postoperatively

  8. Patient Reported Quality of life

    PROMIS-29 (Patient-Reported Outcomes Measurement Information System- Profile 29 incl. proxy-rating)

    Measured: baseline and 3 months postoperatively

  9. Patient Reported Quality of life - 2

    SF-36 (Short Form 36)

    Measured: baseline and 3 months postoperatively

  10. Anxiety and depression

    HADS (Hospital Anxiety and Depression Scale)

    Measured: baseline and 3 months postoperatively

  11. Frailty

    Groningen Frailty Scale

    Measured: baseline and 3 months postoperatively

  12. Structural magnetic resonance imaging

    White matter lesions

    Measured: baseline and 3 months postoperatively

  13. Functional magnetic resonance imaging

    Resting state networks

    Measured: baseline and 3 months postoperatively

  14. Cerebral vasculature

    Ultrasound of extra- and intracranial cerebral arteries

    Measured: baseline

  15. Genetic polymorphisms

    Measured: baseline

Timeline

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

  1. First posted3 Apr 2018
  2. Study start6 Feb 2018
  3. Primary completion31 Mar 2020
  4. Study completion30 Mar 2021

Why it stopped: Recruitment delayed because of Sars-CoV-2 pandemic, elective surgery stopped, funding for undefinite extension not available

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
Case-control
Time perspective
Prospective
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03486288
Sponsor's protocol ID
BB 192/17
Acronym
CONFESS
Status last verified
May 2021
First submitted
1 Mar 2018
Last updated
27 May 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Veser Y, Muller J, Fleischmann A, Leroy S, Ruhnau J, Muller JU, Schroder HWS, Floel A, Fleischmann R. Preoperative depressive symptoms as a marker of postoperative delirium risk in older adults: a prospective cohort study in spine surgery. Front Med (Lausanne). 2026 Sep 15;13:1936636. doi: 10.3389/fmed.2026.1936636. eCollection 2026.

    PubMed 42812328

  • Ruhnau J, Muller J, Nowak S, Strack S, Sperlich D, Pohl A, Dilz J, Rehberg S, Usichenko T, Hahnenkamp K, Weidemeier M, Ehler J, Floel A, Schroeder HWS, Muller JU, Fleischmann R, Vogelgesang A. Exploring Neuroinflammation and Its Role in Postoperative Cognitive Dysfunction following Spine Surgery. Gerontology. 2026;72(1):29-40. doi: 10.1159/000548923. Epub 2025 Oct 20.

    PubMed 41115102

  • Muller J, Nowak S, Vogelgesang A, von Sarnowski B, Rathmann E, Schmidt S, Rehberg S, Usichenko T, Kertscho H, Hahnenkamp K, Floel A, Schroeder HW, Muller JU, Fleischmann R. Evaluating Mechanisms of Postoperative Delirium and Cognitive Dysfunction Following Elective Spine Surgery in Elderly Patients (CONFESS): Protocol for a Prospective Observational Trial. JMIR Res Protoc. 2020 Feb 13;9(2):e15488. doi: 10.2196/15488.

    PubMed 32053113

Questions about this trial

What is this clinical trial studying?

An observational study of Cognitive Impairment and Postoperative Delirium, run by University Medicine Greifswald at 1 site in Germany.

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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 27 May 2021. 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 Germany. 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?

The study was stopped early (reason given: Recruitment delayed because of Sars-CoV-2 pandemic, elective surgery stopped, funding for undefinite extension not available). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative delirium - incidence (time frame: ≤ 3 days postoperatively). 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 NCT03486288, which also lists 3 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 27 May 2021.

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