Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216190
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2005-08-31
Brief Title:
A Safety and Efficacy Study of Dexmedetomidine in ICU Patients Requiring Continuous Sedation
Sponsor:
Hospira now a wholly owned subsidiary of Pfizer
Organization:
Hospira now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Phase 4 Randomized Double-Blind Multi-Center Comparator Study Evaluating the Safety and Efficacy of Dexmedetomidine Compared to IV Midazolam in ICU Subjects Requiring Greater Than Twenty-Four Hours of Continuous Sedation
Status:
COMPLETED
Status Verified Date:
2015-07
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:
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine in ICU subjects who are initially intubated mechanically ventilated and require sedation for beyond 24 hours
Detailed Description:
Traditional agents such benzodiazepines and propofol have long been used to sedate critically ill patients Unfortunately these agents have serious disadvantages that may have a negative impact on patient outcomes These disadvantages include respiratory depression prolonged mechanical ventilation paradoxical agitation myocardial depression hypotension tachyphylaxis physical dependence and an unpredictable duration of action following long term infusions Additionally concomitant use of an opioid or other analgesic is often required for ICU patients to achieve adequate levels of pain relief which may also prolong awakening and possibly increase respiratory depression
Dexmedetomidine may offer a new treatment option that remedies many of the deficiencies of traditional sedatives This agent would provide for accurate titratable sedation and analgesia without the concurrent respiratory depression and accumulation common to other agents It may permit greater patient interaction due to reduced impairment of cognition and may reduce risks associated with opioids due to its analgesia sparing property Although such a drug may have important benefits for ICU patients requiring sedation for greater than 24 hours dexmedetomidine is not currently approved for such long-term usage
Dexmedetomidine may offer a new treatment option that remedies many of the deficiencies of traditional sedatives This agent would provide for accurate titratable sedation and analgesia without the concurrent respiratory depression and accumulation common to other agents It may permit greater patient interaction due to reduced impairment of cognition and may reduce risks associated with opioids due to its analgesia sparing property Although such a drug may have important benefits for ICU patients requiring sedation for greater than 24 hours dexmedetomidine is not currently approved for such long-term usage
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