NICardipine Neuroprotection in AortiC Surgery (NICNACS)

This study has been terminated.
(3/7 subjects experienced hypotension. Study was terminated.)
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00508118
First received: July 25, 2007
Last updated: July 29, 2014
Last verified: January 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Temperature at Which ECS Occurs [ Time Frame: Day of surgery through discharge ] [ Designated as safety issue: No ]
  • Temperature at Which Ablation of(SSEP)Occurs [ Time Frame: Day of surgery through discharge ] [ Designated as safety issue: No ]
  • Time Points of EEG Patterns [ Time Frame: Day of surgery through discharge ] [ Designated as safety issue: No ]
  • Time Points for SSEP Latency and Amplitude Changes [ Time Frame: Day of surgery through discharge ] [ Designated as safety issue: No ]
  • Bispectral Index Scores (BIS) [ Time Frame: Day of surgery through discharge ] [ Designated as safety issue: No ]
  • Cerebral Oximetry Measurements [ Time Frame: Day of surgery through discharge ] [ Designated as safety issue: No ]
  • Transcranial Doppler Measurements [ Time Frame: Day of surgery through discharge ] [ Designated as safety issue: No ]

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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Duke University
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Aortic Arch Reconstruction Surgery

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

ClinicalTrials.gov processed this record on October 22, 2014