Status:
COMPLETED
Preventing ICU Subsyndromal Delirium Conversion to Delirium With Haloperidol
Lead Sponsor:
Northeastern University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Subsyndromal Delirium
Eligibility:
All Genders
18-84 years
Phase:
PHASE4
Brief Summary
About one-third of the patients who develop mild, acute confusion (i.e., subsyndromal delirium) will go on to develop a severe acute confusional state (i.e. delirium). Delirium refers to a temporary c...
Detailed Description
Delirium occurs in up to 50% of patients who are not mechanically ventilated and up to 80% of intensive care unit (ICU) patients who are mechanically ventilated. Even after controlling for preexisting...
Eligibility Criteria
Inclusion
- Age 18-84 years old
- Subsyndromal delirium (ICDSC of 1-3)
- Mechanically ventilated
- No objection from the MICU, CCU, or SICU service attending MD for enrollment
- Admitted to the MICU, CCU, or SICU service at Tufts Medical Center
- Patients is expected by their ICU attending physician to require admission to the ICU for ≥ 24 hours
Exclusion
- Pregnancy
- Delirium (ICDSC ≥ 4)
- History of severe dementia or an Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)) score ≥ 4
- IQCODE is not able to be completed.
- Current treatment with donepezil (aricept), tacrine (cognex), rivastigmine (exelon), or memantine (namenda)
- Admitted with a neurologic diagnosis (e.g., CVA)
- Past diagnosis of schizophrenia or a formal thought disorder as defined by DSM IV criteria.
- Treatment with an antipsychotic agent in the 30 days prior to ICU admission
- Current treatment with a neuromuscular blocker or dexmedetomidine
- A patient requiring a level of sedation equivalent to a sedation-agitation scale (SAS) score ≤ 2
- Inability to conduct valid ICDSC assessment (e.g., coma, deaf)
- Acute alcohol or drug withdrawal
- Acute drug overdose
- Severe encephalopathy
- History of end stage liver failure (based on presence of ≥ 1 or more of the following: AST/ALT ≥ 2 times ULN, INR ≥ 2, total bilirubin ≥ 1.5
- Patients with a baseline QTc interval \>/= 500 msec or an elevation \>/= 60mmHg above baseline
- Current drug therapy with a class Ia, Ic or III antiarrhythmic other than amiodarone.
- History of haloperidol allergy
- History of neuroleptic malignant syndrome.
- Patients expected to die within 24 hours
- Inability to obtain informed consent
- Current participation in another research study.
- Lack of permission of the patient's primary MICU service attending physician for participation in the study.
- Current employment at Tufts Medical Center.
- Age ≥ 85 years.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01174290
Start Date
September 1 2010
End Date
March 1 2014
Last Update
April 14 2017
Active Locations (2)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111
2
Northeastern University
Boston, Massachusetts, United States, 02115