Trial Outcomes & Findings for NICardipine Neuroprotection in AortiC Surgery (NICNACS) (NCT NCT00508118)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Day of surgery

Results posted on

2014-08-01

Participant milestones
Measure	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
Overall Study STARTED	3	4
Overall Study COMPLETED	3	4
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

NICardipine Neuroprotection in AortiC Surgery (NICNACS)

Baseline characteristics by cohort
Measure	Nicardipine n=3 Participants Nicardipine infusion before bypass	0.9% Saline 0.9% saline (placebo) before bypass	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 participants n=5 Participants	—	3 participants n=5 Participants
Age, Categorical >=65 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age, Continuous	50 years STANDARD_DEVIATION 5 • n=5 Participants	—	50 years STANDARD_DEVIATION 5 • n=5 Participants
Gender Female	1 participants n=5 Participants	—	1 participants n=5 Participants
Gender Male	2 participants n=5 Participants	—	2 participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	—	3 participants n=5 Participants

Timeframe: Day of surgery

Population: 3 SUBJECTS PER PROTOCOL.