Valproic Acid for Treatment of Hyperactive or Mixed Delirium in ICU
Launched by STANFORD UNIVERSITY · Jan 21, 2015
Trial Information
Current as of June 13, 2025
Terminated
Keywords
ClinConnect Summary
The investigators plan to investigate the efficacy and tolerability of scheduled VPA as compared to placebo with as needed basis (PRN) haloperidol (as a back-up in both arms) for treatment of hyperactive or mixed delirium. Patients will be randomized to scheduled VPA or placebo (normal saline) and both arms will have flexible PRN dosing of haloperidol. Thus, the investigators plan to learn the time to delirium resolution in patients treated with VPA versus placebo; percentage of patients responding to VPA versus placebo; tolerability of VPA versus placebo. If addition of scheduled VPA prove...
Gender
ALL
Eligibility 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.
About Stanford University
Stanford University is a prestigious academic institution renowned for its cutting-edge research and innovation in healthcare and medicine. As a clinical trial sponsor, Stanford leverages its extensive resources, including a collaborative network of world-class researchers and state-of-the-art facilities, to advance medical knowledge and improve patient care. The university is committed to conducting rigorous, ethical research that adheres to the highest standards of scientific integrity, fostering an environment where groundbreaking discoveries can translate into effective clinical applications. Through its clinical trials, Stanford aims to address critical health challenges and contribute to the development of novel therapies and treatment strategies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Stanford, California, United States
Patients applied
Trial Officials
Yelizaveta Sher, M.D.
Principal Investigator
Stanford University
Jose R Maldonado, M.D.
Study Director
Stanford University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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