Trial Outcomes & Findings for Valproic Acid for Treatment of Hyperactive or Mixed Delirium in ICU (NCT NCT02343575)

NCT ID: NCT02343575

Last Updated: 2019-06-26

Results Overview

Delirium resolution was defined as three negative Confusion Assessment Method (CAM) assessments, performed by nurses every 12 hours.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 3 participants
• Primary outcome timeframe: Up to 5 days
• Results posted on: 2019-06-26

Participant Flow

Participant milestones

Measure	Valproic Acid Participants received Valproic Acid (VPA) and flexible haloperidol as needed.	Placebo Participants received VPA placebo and flexible haloperidol as needed.
Overall Study STARTED	1	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Valproic Acid for Treatment of Hyperactive or Mixed Delirium in ICU

Baseline characteristics by cohort

Measure	Valproic Acid n=1 Participants Participants received VPA and flexible haloperidol as needed.	Placebo n=2 Participants Participants received VPA placebo and flexible haloperidol as needed.	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 days

Delirium resolution was defined as three negative Confusion Assessment Method (CAM) assessments, performed by nurses every 12 hours.

Outcome measures

Measure	Valproic Acid n=1 Participants Participants received VPA and flexible haloperidol as needed.	Placebo n=2 Participants Participants received VPA placebo and flexible haloperidol as needed.
Time to Delirium Resolution	2 days	1.5 days Standard Deviation 0.7

SECONDARY outcome

Timeframe: Up to 5 days

Amount of Haldol administered.

Outcome measures

Measure	Valproic Acid n=1 Participants Participants received VPA and flexible haloperidol as needed.	Placebo n=2 Participants Participants received VPA placebo and flexible haloperidol as needed.
Use of as Needed Anti-psychotic Agent	0 mg	1 mg Standard Deviation 1.2

SECONDARY outcome

Timeframe: Up to 5 days

Side effects may have included liver function test (LFT) increase, platelet decrease, bleeding, or QTc prolongation.

Outcome measures

Measure	Valproic Acid n=1 Participants Participants received VPA and flexible haloperidol as needed.	Placebo n=2 Participants Participants received VPA placebo and flexible haloperidol as needed.
Side Effects From Medications Platelet decrease	0 Participants	0 Participants
Side Effects From Medications LFT increase	0 Participants	0 Participants
Side Effects From Medications Bleeding	0 Participants	0 Participants
Side Effects From Medications QTc prolongation	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 5 days

The items include the assessment of: (1) consciousness ( deep sedation/coma, agitation, normal wakefulness, or light sedation); (2) inattention; (3) disorientation; (4) hallucination, delusion, or psychosis; (5) psychomotor agitation or retardation; (6) inappropriate speech or mood; (7) sleep-wake cycle disturbances; and (8) fluctuation of symptomatology. The maximum score is eight; scores of ≥4 indicate the presence of delirium and score zero is indicate not in delirium. Each item is scored 0-8.

Outcome measures

Measure	Valproic Acid n=1 Participants Participants received VPA and flexible haloperidol as needed.	Placebo n=2 Participants Participants received VPA placebo and flexible haloperidol as needed.
Intensity of Delirium as Measured by the Intensive Care Delirium Screening Checklist (ICDSC) Delirium Severity Scale	5 score on a scale	4 score on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: During expected average hospitalization (of 1 month)

Population: Data were not collected for this outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During expected average hospitalization (of 1 month)

Participation in the study ended once delirium was resolved and the patient was off study drug. This outcome presents the total length of hospital stay, which may have been longer than participation in the study.

Outcome measures

Measure	Valproic Acid n=1 Participants Participants received VPA and flexible haloperidol as needed.	Placebo n=2 Participants Participants received VPA placebo and flexible haloperidol as needed.
Length of Hospital Stay	4 days	8 days Standard Deviation 8.5

Adverse Events

Valproic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Valproic Acid n=1 participants at risk Participants received VPA and flexible haloperidol as needed.	Placebo n=2 participants at risk Participants received VPA placebo and flexible haloperidol as needed.
Cardiac disorders QTc prolongation	0.00% 0/1 • Up to 5 days	50.0% 1/2 • Up to 5 days

Additional Information

Yelizaveta Sher, MD

Stanford University

Phone: 650-736-0459

Email: ysher@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place