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Modafinil Versus Placebo for Hypoactive Delirium in the Critically Ill

NCT ID: NCT02028260

Last Updated: 2016-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-10-31

Brief Summary

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This is a randomized, double-blind, placebo controlled study of 30 patients. Patients who qualify, as per the inclusion criteria (RASS greater than -3, less then +1, CAM positive, present gastric access) will either be given 200mg of modafinil or an identical, indistinguishable placebo. The placebo and study drug will be distributed by the hospital pharmacy. Once enrolled, each patient will be reassessed every morning to determine appropriateness for drug administration. If the RASS is less than -3 (i.e. comatose) or greater then 0 modafinil will not be given. He/she will then be assessed each morning thereafter. Due to the stimulant-like actions of modafinil, the drug will be administered only in the morning. Patients will be assessed for delirium at least twice a day; trained personnel using the Confusion Assessment Method (CAM) will do the assessment. Qualification for a delirium free day will be no positive CAM screens for 24 hours following drug administration. Additional data such as days on mechanical ventilation and progression to tracheotomy will also be collected hypothesizing that patients who take modafinil will have a shorter time to extubation therefore avoiding the need for a tracheotomy. Post-discharge from the unit, but within 48 hours, patients will be asked to participate in a survey (The Richards-Campbell Sleep Questionnaire (RCSQ) assessing their perception of daytime and nighttime sleepiness in the intensive care unit as well as their overall perception of rest. Their functional capacity will also be evaluated at this time and compared to their pre-morbid baseline. The hypothesis tested is that Modafinil restores sleep cycle synchrony in the ICU therefore increasing delirium free days and improving ICU outcomes.

Detailed Description

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Eligibility Criteria

Inclusion Criteria To be eligible for study entry, subjects must satisfy these main criteria

Inclusion criteria:

3.1 Inclusion Criteria

* Adult patients ≥ 18 yrs of age, \< 76 yrs of age
* Admitted to MICU (3B and 3C) or SICU (8C, 8D, 11C)
* Surrogate present to provide informed consent when patient is not able
* RASS score of \>-3, \< +1
* CAM positive
* Enteral access

3.2 Exclusion Criteria:

* Recent MI (within past 2 weeks)
* High risk of dysrhythmias (i.e. bundle branch block, QT prolongation, class IV HF, implanted device)
* Unable to tolerate enteral medication
* History of stimulant induced mania/psychosis
* Pre-existing neurologic disease
* Patients transferred from outside hospital
* Pregnancy
* Alcohol withdrawal
* History of end stage liver disease (Childs-Pugh class B or worse)
* Prognosis considered hopeless (CMO)

Conditions

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Delirium Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Modafinil

Modafinil 200 mg qAM enterally for the duration the patient is confirmed to be in a hypoactive delirium to a maximum of 14 days.

Group Type ACTIVE_COMPARATOR

Modafinil

Intervention Type DRUG

200 mg daily

Placebo

normal saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

similar appearing inert tablet

Interventions

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Modafinil

200 mg daily

Intervention Type DRUG

Placebo

similar appearing inert tablet

Intervention Type DRUG

Other Intervention Names

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provigil

Eligibility Criteria

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Inclusion Criteria

* Adult patients ≥ 18 yrs of age, \< 76 yrs of age
* Admitted to MICU (3B and 3C) or SICU (8C, 8D, 11C)
* Surrogate present to provide informed consent when patient is not able
* RASS score of \>-3, \< +1
* CAM positive
* Enteral access

Exclusion Criteria

* Recent MI (within past 2 weeks)
* High risk of dysrhythmias (i.e. bundle branch block, QT prolongation, class IV HF, implanted device)
* Unable to tolerate enteric medication
* History of stimulant induced mania/psychosis
* Pre-existing neurologic disease
* Patients transferred from outside hospital
* Pregnancy
* Alcohol withdrawal
* History of end stage liver disease (Childs-Pugh class B or worse)
* Prognosis considered hopeless (CMO)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gerald L. Weinhouse

BWPO PHYSICIAN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerald L Weinhouse, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2013P002105

Identifier Type: -

Identifier Source: org_study_id