NICardipine Neuroprotection in AortiC Surgery (NICNACS)

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT00508118
Phase
PHASE2
Status
Terminated

Conditions

  • Aortic Aneurysm, Thoracic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nicardipine — DRUG
    on bypass
  • 0.9% saline — DRUG
    on bypass

Study Details

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.

Key Dates

Start date
Jan 31, 2008
Status verified
Jan 2013
Primary completion
Apr 30, 2008
Completion
Apr 30, 2008

Study Design

Enrollment
7 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Nicardipine
  • Placebo Comparator: 2
    0.9% saline

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NC

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