Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096863
Status:
COMPLETED
Last Update Posted:
2016-01-29
First Post:
2004-11-16
Brief Title:
The MIND Study Modifying the INcidence of Delirium
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Delirium in the ICU a Prospective Randomized Trial of Placebo vs Haloperidol vs Ziprasidone
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Delirium is associated with increased risk of death prolonged stay higher cost of care and likely long-term brain deficits in survivors This form of brain dysfunction occurs in intensive care unit ICU patients in epidemic proportions and the scope of this problem is likely to worsen in upcoming years due to the aging of our population and increased utilization of the ICU Currently delirium goes unrecognized and untreated in the vast majority of circumstances in the ICU unless the patient presents with hyperactive delirium and agitation In the latter circumstance a commonly used typical antipsychotic called haloperidol is considered the principal agent for treating delirium based largely on anecdotal evidence to support its usefulness though no placebo controlled trials exist There are no FDA approved medications for delirium The atypical antipsychotics provide a promising alternative for the treatment of delirium due to their enhanced beneficial effects on positive agitated and negative quiet symptoms proven in mania and schizophrenia reduced risk for side effects common to haloperidol such as extrapyramidal symptomatology and less potentially lethal heart rhythm disturbances It is imperative that well-designed phase II studies to determine proof of principle be conducted A pilot study of feasibility to begin assessing the role of antipsychotics in the management of ICU delirium
Detailed Description:
This investigation will be the first placebo controlled trial of delirium preventiontreatment in or out of the ICU As mentioned above clinical practice guidelines for medical management of pain anxiety and delirium major determinants of patient comfort are endorsed by the major critical care societies These guidelines will form the template for this investigation Pain management is prioritized as a clinicians first concern The assessment and treatment algorithm in the guidelines then places anxiety and delirium respectively as sequential tiers of priority While delirium monitoring is now available recent data indicate that less than 5 of practicing ICU healthcare professionals use a specific delirium monitoring instrument Thus as outlined here most delirium is not recognized or treated which serves as the rationale for this placebo-controlled investigation Anxiety is currently treated with drugs such as benzodiazepines Such anxiety however may be due to delirium in which case treatment with anxiolytics such as benzodiazepines might exacerbate this form of brain dysfunction On the other hand it is possible that treatment with antipsychotics will reduce the duration and severity of delirium result in less breakthrough sedatives due to the sedating effects of the antipsychotics and improve clinical outcomes Alternatively treatment with antipsychotics may not alter or worsen clinical outcomes
The specific aims of this study are as follows
Aim 1 To determine whether antipsychotics reduce the incidence and duration of delirium in high risk mechanically ventilated patients
Aim 2 To determine whether antipsychotics reduce the severity of neuropsychological dysfunction at hospital discharge in high risk mechanically ventilated patients
Hypothesis 1 Our primary hypothesis is that in mechanically ventilated patients the duration of delirium and the days alive and free of delirium - as measured using the Confusion Assessment Method for the ICU CAM-ICU- will be significantly improved by early treatment with antipsychotics haloperidol or ziprasidone as compared to placebo Furthermore we hypothesize that delirium duration will be comparable between the two intervention groups haloperidol and ziprasidone To test the primary hypothesis we propose to perform a randomized double-blind placebo-controlled trial of the preventiontreatment of delirium in ICU patients using oral liquid formulations of haloperidol versus ziprasidone versus placebo This study is powered to show a 50 improvement in the duration of delirium CAM-ICU positive days and will enroll 102 patients 34 in each group over a two-year period In addition we will compare between groups the overall incidence of delirium and the number of delirium free days DFDs - defined as days alive and free of coma and delirium to day 21
Hypothesis 2 We hypothesize that scores on a neuropsychological testing battery administered at the time of hospital discharge will be better in patients treated with antipsychotics either haloperidol or ziprasidone than those treated with placebo Furthermore we hypothesize that neuropsychological test scores will be comparable between the two intervention groups haloperidol and ziprasidone
The specific aims of this study are as follows
Aim 1 To determine whether antipsychotics reduce the incidence and duration of delirium in high risk mechanically ventilated patients
Aim 2 To determine whether antipsychotics reduce the severity of neuropsychological dysfunction at hospital discharge in high risk mechanically ventilated patients
Hypothesis 1 Our primary hypothesis is that in mechanically ventilated patients the duration of delirium and the days alive and free of delirium - as measured using the Confusion Assessment Method for the ICU CAM-ICU- will be significantly improved by early treatment with antipsychotics haloperidol or ziprasidone as compared to placebo Furthermore we hypothesize that delirium duration will be comparable between the two intervention groups haloperidol and ziprasidone To test the primary hypothesis we propose to perform a randomized double-blind placebo-controlled trial of the preventiontreatment of delirium in ICU patients using oral liquid formulations of haloperidol versus ziprasidone versus placebo This study is powered to show a 50 improvement in the duration of delirium CAM-ICU positive days and will enroll 102 patients 34 in each group over a two-year period In addition we will compare between groups the overall incidence of delirium and the number of delirium free days DFDs - defined as days alive and free of coma and delirium to day 21
Hypothesis 2 We hypothesize that scores on a neuropsychological testing battery administered at the time of hospital discharge will be better in patients treated with antipsychotics either haloperidol or ziprasidone than those treated with placebo Furthermore we hypothesize that neuropsychological test scores will be comparable between the two intervention groups haloperidol and ziprasidone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None