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Dexmedetomidine for Postoperative Sedation in Patients Undergoing Repair of Thoracoabdominal Aortic Aneurysms

This study has been terminated.
(Surgical approach changed therefore subject enrollment not possible.)
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00409344
First received: December 7, 2006
Last updated: September 16, 2009
Last verified: September 2009
Results First Received: February 26, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Conditions: Sedation
Respiration, Artificial
Length of Stay
Interventions: Drug: Dexmedetomidine
Other: Normal Saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period 10/10/2006 to 1/1/2008 from a surgical intensive care unit in a tertiary hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Unable to enroll participants due to hepatic impairment and many patients taking tricyclic antidepressants.

Reporting Groups
  Description
Saline This group will recive saline
Dexmedetomidine This group will receive dexmedetomidine

Participant Flow:   Overall Study
    Saline     Dexmedetomidine  
STARTED     0 [1]   0 [1]
COMPLETED     0 [2]   0 [2]
NOT COMPLETED     0     0  
no enrollment                 0                 0  
[1] No participants enrolled
[2] No participants were enrolled to completion



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Saline This group will recive saline
Dexmedetomidine This group will receive dexmedetomidine
Total Total of all reporting groups

Baseline Measures
    Saline     Dexmedetomidine     Total  
Number of Participants  
[units: participants]
  0     0     0  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     0     0     0  
Male     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to a Successful Spontaneous Breathing Trial.   [ Time Frame: 1/1/2008 ]

2.  Primary:   Intensive Care Unit Length of Stay   [ Time Frame: 1/1/2008 ]

3.  Secondary:   Secondary Endpoints Include:Amount of Sedative and Opiates Given   [ Time Frame: 1/1/2008 ]

4.  Secondary:   Time to Extubation   [ Time Frame: 1/1/2008 ]

5.  Secondary:   Amount of Vasoactive Substances Used to Achieve Hemodynamic Stability   [ Time Frame: 1/1/2008 ]

6.  Secondary:   Pharmaco-economics   [ Time Frame: 1/1/2008 ]

7.  Secondary:   Incidence of Delirium; Number of Shifts During Which Delirium Was Diagnosed   [ Time Frame: 1/1/2008 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Unable to enroll participants into the study


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ulrich Schmidt, MD PhD
Organization: Massachusetts General Hospital
phone: 617-724-6490
e-mail: uschmidt@partners.org


No publications provided


Responsible Party: Ulrich Schmidt, MD PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00409344     History of Changes
Other Study ID Numbers: 2006-P-001827, IND:74068
Study First Received: December 7, 2006
Results First Received: February 26, 2009
Last Updated: September 16, 2009
Health Authority: United States: Food and Drug Administration