Valproic Acid for Treatment of Hyperactive or Mixed Delirium in ICU

• Status: Terminated
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Delirium is the most often encountered psychiatric diagnosis in the general hospital, with incidence up to 85% in the intensive care unit (ICU) setting and with significant consequences on patients' morbidity and mortality. Currently, although not FDA approved, antipsychotics are often considered the first-line pharmacological treatment. However, there can be limitations to their use, including side effects or lack of efficacy. Valproic acid (VPA) is one of the alternatives at times used in such patients which from limited case series data appears to be helpful and tolerated. VPA can provide relief from agitation that poses a threat to the safety and recovery of the patient. Moreover, mechanistically it addresses the neurochemical and cellular abnormalities inherent in delirium (it has NMDA-antagonist, anti-dopaminergic, GABAergic,anti-inflammatory, anti-apoptotic, and histone deacetylase inhibitor properties, among others). The purpose of this study is to evaluate the efficacy and tolerability of the VPA in the first known to us randomized controlled trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Haloperidol; Haloperidol decanoate; Valproic Acid

Criteria

Inclusion Criteria:

• patients 18 years of age and older

• admitted to surgical ICU

• diagnosed with hyperactive or mixed delirium

Exclusion Criteria:

• hypoactive delirium

• primary team does not think patient is appropriate to participate

• no oral access (PO or NGT)

• non-English speaking

• contraindication to study medications

• pregnant women or woman of child-bearing age not on documented contraception

• QTc = or greater than 480

• hepatic dysfunction

• decreased platelets or platelet dysfunction

• bleeding disorder, current major bleeding

• history of NMS, epilepsy, or PD

• diagnosis of schizophrenia, bipolar disorder or schizoaffective disorder

• on warfarin or carbapenems

• delirium due to alcohol withdrawal

• treated with antipsychotics for more than 48 hours prior to study enrollment.