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Trial record 49 of 240 for:    (armodafinil)

Modafinil Versus Placebo for Hypoactive Delirium in the Critically Ill

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ClinicalTrials.gov Identifier: NCT02028260
Recruitment Status : Withdrawn (unable to enroll)
First Posted : January 7, 2014
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Gerald L. Weinhouse, Brigham and Women's Hospital

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)

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Study Type : Interventional  (Clinical Trial)
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 : January 2014
Estimated Primary Completion Date : July 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

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 Name: provigil

Placebo Comparator: Placebo
normal saline
Drug: Placebo
similar appearing inert tablet




Primary Outcome Measures :
  1. Decreased CAM positive days in the ICU [ Time Frame: Up to 14 days of ICU stay ]

Secondary Outcome Measures :
  1. Length of stay in the ICU [ Time Frame: Up to 14 days of ICU stay ]

Other Outcome Measures:
  1. Patients perception of their sleep pattern in the ICU [ Time Frame: Up to 14 days of ICU stay ]
  2. Return to baseline activities of daily living (ADL's) [ Time Frame: Up to 14 days of ICU stay ]
  3. Amount of psychotropic medication co-administered [ Time Frame: Up to 14 days of ICU stay ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02028260


Locations
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United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Gerald L Weinhouse, MD Brigham and Women's Hospital

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Responsible Party: Gerald L. Weinhouse, BWPO PHYSICIAN, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02028260     History of Changes
Other Study ID Numbers: 2013P002105
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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Modafinil
Critical Illness
Delirium
Respiratory Insufficiency
Disease Attributes
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action