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Recruiting
NCT06382649
Rivastigmine for Antimuscarinic Delirium
Conditions: Anticholinergic Toxicity
Sex: All
Ages: 10 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 42
Sponsor: Washington University School of Medicine
Location: Washington University School of Medicine St Louis Missouri
Summary
Antimuscarinic delirium (AMD) is a common and dangerous toxicology condition caused by poisoning by medications and other chemicals that block muscarinic receptors. Physostigmine, the standard antidote for AMD, currently has very limited availability in the United States due to an interruption of production.
Recent case reports and small observational studies suggest that rivastigmine might be useful in the treatment of AMD, but there is not direct prospective evidence comparing rivastigmine to physostigmine or supportive care. In order to investigate the effectiveness of rivastigmine, the investigators propose a randomized, placebo-controlled clinical trial of rivastigmine for AMD. The investigators hypothesize that patients treated with rivastigmine for antimuscarinic delirium will experience more rapid resolution of agitation and delirium than those treated with placebo.
Eligibility Criteria
Inclusion Criteria:
* 10 years of age or older
* Diagnosis of antimuscarinic delirium by history and physical examination, in the opinion of the treating attending toxicologist.
* Reasonably likely to benefit from antidotal therapy for antimuscarinic delirium, as demonstrated by clinically significant agitation and delirium:
1. Richmond Agitation-Sedation Scale (RASS) of +1 or higher at the time of enrollment
2. Positive for delirium as defined by the Confusion Assessment Method for the ICU (CAM-ICU)
Exclusion Criteria:
* Age less than 10 years at time of enrollment
* Surrogate decision maker not available to provide informed consent for enrollment.
* Patient is pregnant or a ward of the state.
* Inability to safely tolerate oral medication, in the judgement of the treating attending physician.
* Evidence of significant risk for serious cardiac or neurologic sequelae of antimuscarinic poisoning:
a. Any known or suspected seizure activity prior to enrollment b. QRS duration \>100 milliseconds on EKG at enrollment c. Any ventricular dysrhythmia prior to enrollment d. Respiratory failure of any etiology requiring endotracheal intubation e. Any hypotension at enrollment: i. Adults: systolic blood pressure (SBP) \
Source: ClinicalTrials.gov (NCT06382649). StuddyBuddy aggregates publicly available trial information.
