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Search / Trial NCT01487317

Rivastigmine in the Management of Delirium

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Dec 6, 2011

Trial Information

Current as of June 17, 2025

Completed

Keywords

Delirium Acetylcholinesterase Inhibitor Elderly Emergency Department

ClinConnect Summary

Delirium affects up to 50% of hospitalized patients aged 75 and over. Delirium increases risk of comorbid illness, hospital length of stay, institutionalization, and death. Patients with diagnosed or undiagnosed cognitive impairment are at risk to develop delirium. In a prospective study, half of elderly patients with delirium seen in the emergency department had cognitive impairment.

Hypothesis: cholinesterase inhibitors reduce duration and severity of delirium

Main objective:

- to assess the efficacy of cholinesterase inhibitors in patients aged 75 and over hospitalized with delirium

...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients aged 75 and over
  • Hospitalization for delirium not correlated to surgery for less than 48 hours
  • Patients with delirium requiring the presence of features 1 (acute onset and fluctuation course), 2 (inattention), 3 (disorganized thinking) and 4 (altered level of consciousness) of the Confusion Assessment Model and DRS R-98 \> 10
  • Absence of any contraindications to a cholinesterase inhibitor treatment
  • Health insurance affiliation
  • Having signed an informed consent form
  • Caregiver/informant to provide information on patient
  • Exclusion Criteria:
  • Use of IAchE or memantine medication
  • Contraindication to IAchE medication
  • Frontotemporal dementia
  • Diseases involving the short-term survival
  • Digestive bleeding
  • Ischemic and hemorrhagic stroke related to actual onset (including hemorrhagic contusion)
  • Natremia ≤120 mmol/l at the time of hospitalization
  • Post epileptic confusion
  • Hepato-cellular failure
  • Cardiorespiratory impairment at risk of transfer to intensive care unit
  • Major sensory deficits that could interfere with cognitive assessment (visual and auditory)
  • Not fluent in French
  • Being under guardianship
  • Absence of caregiver/informant to sign informed consent form

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Paris, , France

Patients applied

0 patients applied

Trial Officials

Marc Verny, MD, PhD

Principal Investigator

Assistance Publique - Hôpitaux de Paris

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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