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Trial record 21 of 100 for:    "thoracic aortic aneurysms and aortic dissections" OR "Aortic Aneurysm, Thoracic"

NICardipine Neuroprotection in AortiC Surgery (NICNACS) (NICNACS)

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ClinicalTrials.gov Identifier: NCT00508118
Recruitment Status : Terminated (3/7 subjects experienced hypotension. Study was terminated.)
First Posted : July 27, 2007
Results First Posted : March 8, 2013
Last Update Posted : August 1, 2014
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Aortic Aneurysm, Thoracic
Interventions: Drug: Nicardipine
Drug: 0.9% saline

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Nicardipine

Nicardipine infusion before bypass

After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available.

0.9% Saline 0.9% saline (placebo) infusion before bypass

Participant Flow:   Overall Study
    Nicardipine   0.9% Saline
STARTED   3   4 [1] 
COMPLETED   3   4 
NOT COMPLETED   0   0 
[1] Documentation is not available for the 7th subject and treatment arm.



  Baseline Characteristics

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
Nicardipine Nicardipine infusion before bypass
0.9% Saline 0.9% saline (placebo) before bypass
Total Total of all reporting groups

Baseline Measures
   Nicardipine   0.9% Saline   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   0   3 
Age 
[Units: Participants]
     
<=18 years   0      0 
Between 18 and 65 years   3      3 
>=65 years   0      0 
Age 
[Units: Years]
Mean (Standard Deviation)
 50  (5)      50  (5) 
Gender 
[Units: Participants]
     
Female   1      1 
Male   2      2 
Region of Enrollment 
[Units: Participants]
     
United States   3      3 


  Outcome Measures

1.  Primary:   Duration From Initiation of Cardiopulmonary Bypass (CPB) to Electrocerebral Silence (ECS), Defined as no Discernable Electroencephalographic Activity at an Amplification of 2 Micro Volts (μV)/mm, Confirmed for 3 Minutes   [ Time Frame: Day of surgery ]

2.  Secondary:   Temperature at Which ECS Occurs   [ Time Frame: Day of surgery through discharge ]

3.  Secondary:   Temperature at Which Ablation of(SSEP)Occurs   [ Time Frame: Day of surgery through discharge ]

4.  Secondary:   Time Points of EEG Patterns   [ Time Frame: Day of surgery through discharge ]

5.  Secondary:   Time Points for SSEP Latency and Amplitude Changes   [ Time Frame: Day of surgery through discharge ]

6.  Secondary:   Bispectral Index Scores (BIS)   [ Time Frame: Day of surgery through discharge ]

7.  Secondary:   Cerebral Oximetry Measurements   [ Time Frame: Day of surgery through discharge ]

8.  Secondary:   Transcranial Doppler Measurements   [ Time Frame: Day of surgery through discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
This study was terminated early because of safety concerns in the active treatment group. In 3 patients randomized, the blind was broken in 3 because of refractory hypotension and acidosis requiring vasopressor therapy. All 3 were on active drug.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Andrew Shaw MD
Organization: Duke University Medical Center
phone: 919 286 6938
e-mail: andrew.shaw@duke.edu


Publications:


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00508118     History of Changes
Other Study ID Numbers: Pro00001612
First Submitted: July 25, 2007
First Posted: July 27, 2007
Results First Submitted: September 21, 2011
Results First Posted: March 8, 2013
Last Update Posted: August 1, 2014