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Trial record 21 of 101 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

Brief Summary:

Objective

The objective of this study is to discover whether an infusion of nicardipine is able to reduce the time taken to achieve electrocerebral silence (ECS) during cardiopulmonary bypass (CPB) for aortic surgery.

Hypothesis

By inhibiting cold-induced cerebral vasoconstriction, nicardipine will maintain cerebral blood flow and allow more rapid cooling of the brain during CPB. This will manifest as a reduction in the time taken to achieve ECS and also as a reduction in overall CPB time.


Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Thoracic Drug: Nicardipine Drug: 0.9% saline Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: NICardipine Neuroprotection in AortiC Surgery (NICNACS)
Study Start Date : January 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Nicardipine
Drug: Nicardipine
on bypass

Placebo Comparator: 2
0.9% saline
Drug: 0.9% saline
on bypass




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Temperature at Which ECS Occurs [ Time Frame: Day of surgery through discharge ]
  2. Temperature at Which Ablation of(SSEP)Occurs [ Time Frame: Day of surgery through discharge ]
  3. Time Points of EEG Patterns [ Time Frame: Day of surgery through discharge ]
  4. Time Points for SSEP Latency and Amplitude Changes [ Time Frame: Day of surgery through discharge ]
  5. Bispectral Index Scores (BIS) [ Time Frame: Day of surgery through discharge ]
  6. Cerebral Oximetry Measurements [ Time Frame: Day of surgery through discharge ]
  7. Transcranial Doppler Measurements [ Time Frame: Day of surgery through discharge ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult (>18 years) patients at Duke University Medical Center (DUMC) presenting for elective aortic surgery scheduled to include a period of deep hypothermic circulatory arrest.

Exclusion Criteria:

  • Failure to provide written informed consent
  • Emergency operation
  • Documented allergy to nicardipine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508118


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Andy Shaw, M. D. Duke University Health System

Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00508118     History of Changes
Other Study ID Numbers: Pro00001612
First Posted: July 27, 2007    Key Record Dates
Results First Posted: March 8, 2013
Last Update Posted: August 1, 2014
Last Verified: January 2013

Keywords provided by Duke University:
Aortic Arch Reconstruction Surgery

Additional relevant MeSH terms:
Aortic Aneurysm, Thoracic
Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Nicardipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents