NCT03486288: CONFESS

Cognitive Impairment Following Elective Spine Surgery

Terminated Last updated 27 May 2021

What this trial tests

trial in Cognitive Impairment in 124 participants. Terminated before completion.

Timeline

6 February 2018

Primary endpoint
31 March 2020

30 March 2021

Quick facts

Lead sponsor	University Medicine Greifswald
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	124
Start date	6 February 2018
Primary completion	31 March 2020
Estimated completion	30 March 2021
Sites	1 location across Germany

Conditions studied

• Cognitive Impairment — all drugs for Cognitive Impairment →
• Postoperative Delirium — all drugs for Postoperative Delirium →
• Spine Fusion — all drugs for Spine Fusion →

Sponsor

University Medicine Greifswald

Who can join

60 and older, any sex, with Cognitive Impairment or Postoperative Delirium. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Serum Biomarkers of a Pro-Neuroinflammatory State May Define the Pre-Operative Risk for Postoperative Delirium in Spine Surgery.
   Ruhnau J, Müller J, Nowak S, Strack S, et al · · 2023 · cited 25× · PMID 37373482 · DOI 10.3390/ijms241210335
2. Evaluating Mechanisms of Postoperative Delirium and Cognitive Dysfunction Following Elective Spine Surgery in Elderly Patients (CONFESS): Protocol for a Prospective Observational Trial.
   Müller J, Nowak S, Vogelgesang A, von Sarnowski B, et al · · 2020 · cited 13× · PMID 32053113 · DOI 10.2196/15488
3. Duration of Surgery and Intraoperative Blood Pressure Management Are Modifiable Risk Factors for Postoperative Neurocognitive Disorders After Spine Surgery: Results of the Prospective CONFESS Study.
   Müller J, Nowak S, Weidemeier M, Vogelgesang A, et al · · 2023 · cited 12× · PMID 37195031 · DOI 10.1097/brs.0000000000004722
4. Exploring Neuroinflammation and Its Role in Postoperative Cognitive Dysfunction following Spine Surgery.
   Ruhnau J, Müller J, Nowak S, Strack S, et al · · 2026 · cited 1× · PMID 41115102 · DOI 10.1159/000548923
5. Complement Activation as a Predictor of Postoperative Delirium in Elderly Spine Surgery Patients.
   Vogelgesang A, Wolf H, Strack S, Flöel A, et al · · 2026 · PMID 41596720 · DOI 10.3390/ijms27021077
6. Cerebrovascular pulsatility indicates preoperative subcortical cognitive impairment and an increased risk for postoperative delirium in elderly patients undergoing elective spine surgery.
   Saar A, Müller J, Veser Y, Behr F, et al · · 2024 · PMID 39380730 · DOI 10.3389/fmed.2024.1433380