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NICardipine Neuroprotection in AortiC Surgery (NICNACS) (NICNACS)

This study has been terminated.
(3/7 subjects experienced hypotension. Study was terminated.)
Information provided by (Responsible Party):
Duke University Identifier:
First received: July 25, 2007
Last updated: July 29, 2014
Last verified: January 2013


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.


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 Intervention Phase
Aortic Aneurysm, Thoracic Drug: Nicardipine Drug: 0.9% saline Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: NICardipine Neuroprotection in AortiC Surgery (NICNACS)

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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:
  • Temperature at Which ECS Occurs [ Time Frame: Day of surgery through discharge ]
  • Temperature at Which Ablation of(SSEP)Occurs [ Time Frame: Day of surgery through discharge ]
  • Time Points of EEG Patterns [ Time Frame: Day of surgery through discharge ]
  • Time Points for SSEP Latency and Amplitude Changes [ Time Frame: Day of surgery through discharge ]
  • Bispectral Index Scores (BIS) [ Time Frame: Day of surgery through discharge ]
  • Cerebral Oximetry Measurements [ Time Frame: Day of surgery through discharge ]
  • Transcranial Doppler Measurements [ Time Frame: Day of surgery through discharge ]

Enrollment: 7
Study Start Date: January 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Nicardipine
on bypass
Placebo Comparator: 2
0.9% saline
Drug: 0.9% saline
on bypass

  Show Detailed Description


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00508118

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


Responsible Party: Duke University Identifier: NCT00508118     History of Changes
Other Study ID Numbers: Pro00001612
Study First Received: July 25, 2007
Results First Received: September 21, 2011
Last Updated: July 29, 2014

Keywords provided by Duke University:
Aortic Arch Reconstruction Surgery

Additional relevant MeSH terms:
Aortic Aneurysm, Thoracic
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents processed this record on August 18, 2017