Modafinil Versus Placebo for Hypoactive Delirium in the Critically Ill

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02028260

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium Respiratory Failure	Drug: Modafinil Drug: Placebo	Phase 3

Detailed Description

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)

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Modafinil vs. Placebo for Hypoactive Delirium in the Critically Ill: A Randomized, Controlled Trial

Study Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Modafinil 200 mg daily Other Names: provigil
Placebo Comparator: Placebo normal saline	Drug: Placebo similar appearing inert tablet

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Modafinil

200 mg daily

Other Names:

provigil

Placebo Comparator: Placebo

normal saline

Drug: Placebo

similar appearing inert tablet

Outcome Measures

Primary Outcome Measures

Decreased CAM positive days in the ICU [Up to 14 days of ICU stay]

Secondary Outcome Measures

Length of stay in the ICU [Up to 14 days of ICU stay]

Other Outcome Measures

Patients perception of their sleep pattern in the ICU [Up to 14 days of ICU stay]
Return to baseline activities of daily living (ADL's) [Up to 14 days of ICU stay]
Amount of psychotropic medication co-administered [Up to 14 days of ICU stay]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham & Women's Hospital	Boston	Massachusetts	United States	02115
2	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

Principal Investigator: Gerald L Weinhouse, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gerald L. Weinhouse, BWPO PHYSICIAN, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT02028260

Other Study ID Numbers:

2013P002105

First Posted:

Jan 7, 2014

Last Update Posted:

Nov 3, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Respiratory Insufficiency

Delirium

Modafinil

Study Results

No Results Posted as of Nov 3, 2016