Washington University School of Medicine
St Louis, Missouri, 63110, United States
Location status: Recruiting
NCT Number: NCT06382649
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.
Interested in participating?
Request Info10 year and older
All sexes
Interventional
Phase 2
St Louis, Missouri, 63110, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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) <90 mmHg ii. Children ≥10: systolic blood pressure (SBP) <90 mmHg, as per Pediatric Advanced Life Support (PALS) age-based cutoff for children 10 years of age or older3 f. Any administration of sodium bicarbonate, hypertonic saline, vasopressors, inotropes, antiarrhythmic agents, or intravenous lipid emulsion prior to enrollment.
g. Unacceptable risk of serious medical sequelae of antimuscarinic poisoning in the judgment of the treating attending toxicologist.
a.Bradycardia or risk of AChE-I induced bradycardia at enrollment: i. Adults: heart rate (HR) <80 beats per minute ii. Children: heart rate below the median heart rate for age as proposed by Fleming et al.33:
e. Known or suspected peptic ulcer disease.
Rivastigmine 3mg by mouth once, followed by rivastigmine 1.5mg by mouth every 1 hour as needed for ongoing delirium or agitation (at the discretion of the treating physician), for a maximum of three doses
Matching oral placebo by mouth once, followed by placebo by mouth every 1 hour as needed for ongoing delirium or agitation (at the discretion of the treating physician), for a maximum of three doses
Time frame: Typically 8-36 hours after randomization
Time from study drug administration to control of agitation and delirium, as defined by a Richmond Agitation-Sedation Scale (RASS) of 0 or -1 and a negative Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). RASS and CAM-ICU will be assessed by trained study personnel at the patient's bedside every 2 hours until sustained recovery (defined as absence of agitation and delirium on four consecutive assessments).
Time frame: Typically 8-36 hours after randomization
Total duration of time during which patient is experiencing agitation and delirium (defined and assessed as above)
Time frame: Typically 8-36 hours after randomization
Total amount of sedatives (antipsychotics, benzodiazepines, dexmedetomidine, propofol, fentanyl, ketamine) administered during the study period.
Time frame: Typically 8-36 hours after randomization
Any use of continuous sedative infusion (dexmedetomidine, benzodiazepine, propofol, fentanyl) during the study period.
Time frame: Typically 8-36 hours after randomization
Any use of physical restraints during the study period
Time frame: Typically 8-36 hours after randomization
Disposition to ICU, stepdown/intermediate care unit, or floor level of care
Time frame: Typically 8-36 hours after randomization
Time from presentation to medical clearance by the toxicology consult service
Time frame: Typically 8-36 hours after randomization
Incidence of oversedation, defined as RASS lower than -2
Time frame: Typically 8-36 hours after randomization
Incidence of intubation and mechanical ventilation during the study period
Time frame: Typically 8-36 hours after randomization
Incidence of epileptic seizure during the study period
Time frame: Typically 8-36 hours after randomization
Incidence of clinically significant gastrointestinal upset during the study period
Time frame: Typically 8-36 hours after randomization
Incidence of any bradycardia (as defined using age-based heart rate cutoffs) during the study period
Contact information is provided by the study sponsor or research team.
Washington University School of Medicine
Other
Rivastigmine for Antimuscarinic Delirium: a Randomized, Placebo-controlled Trial
Acronym: RIVA-AM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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