NCT00464763

A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Heart Surgery

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Two-Arm Parallel, Multicenter Study Evaluating the Efficacy and Safety of Dexmedetomidine in the Prevention of Postoperative Delirium in Subjects Undergoing Heart Surgery With Cardiopulmonary Bypass

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hospira, now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the prevention of postoperative delirium in subjects undergoing heart valve surgery with or without coronary artery bypass surgery (CABG) using cardiopulmonary bypass (CPB).

Detailed description

Postoperative delirium is an acute decline in cognition and attention which is usually transient but when delirium persists, it can impact cognitive function, morbidity and mortality. Currently, there are no drugs to prevent delirium but dexmedetomidine has the potential to meet this unmet medical need. Dexmedetomidine is currently approved for use for 24 hours in patients on ventilators in the Intensive Care Unit(ICU). This study is to determine whether or not dexmedetomidine can prevent delirium after heart surgery. Study participation will last from randomization prior to surgery, to 3 days after surgery. Dexmedetomidine will be given through an intravenous catheter beginning at sternal closure and continue throughout the stay in the ICU. Delirium will be assessed prior to surgery and for 72 hours after surgery. This assessment will consist of questions that will evaluate memory and thought process. Thirty days after surgery, questions will be asked regarding the patients feelings about their health status and hospital billing information will be collected.

Conditions

• Delirium

Interventions

Type	Name	Description
DRUG	Dexmedetomidine
DRUG	Placebo

Timeline

• Start date: 2007-04-01
• Completion: 2007-09-01
• First posted: 2007-04-24
• Last updated: 2017-03-21

Locations

11 sites across 1 country: United States