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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Aortic Aneurysm, Thoracic
Interventions Drug: Nicardipine
Drug: 0.9% saline
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nicardipine 0.9% Saline
Hide Arm/Group Description

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 (placebo) infusion before bypass
Period Title: Overall Study
Started 3 4 [1]
Completed 3 4
Not Completed 0 0
[1]
Documentation is not available for the 7th subject and treatment arm.
Arm/Group Title Nicardipine 0.9% Saline Total
Hide Arm/Group Description Nicardipine infusion before bypass 0.9% saline (placebo) before bypass Total of all reporting groups
Overall Number of Baseline Participants 3 0 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 3 participants
<=18 years 0 0
Between 18 and 65 years 3 3
>=65 years 0 0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 0 participants 3 participants
50  (5) 50  (5)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 3 participants
Female 1 1
Male 2 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 0 participants 3 participants
3 3
1.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Day of surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
3 SUBJECTS PER PROTOCOL.
Arm/Group Title NICARDIPINE GROUP
Hide Arm/Group Description:
Nicardipine prior to bypass
Overall Number of Participants Analyzed 3
Median (95% Confidence Interval)
Unit of Measure: Time (minutes)
45
(35 to 56)
2.Secondary Outcome
Title Temperature at Which ECS Occurs
Hide Description [Not Specified]
Time Frame Day of surgery through discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants analyzed due to study terminated early.
Arm/Group Title Nicardipine 0.9% Saline
Hide Arm/Group Description:

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 (placebo) infusion before bypass
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Temperature at Which Ablation of(SSEP)Occurs
Hide Description [Not Specified]
Time Frame Day of surgery through discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed due to study terminated early.
Arm/Group Title Nicardipine 0.9% Saline
Hide Arm/Group Description:

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 (placebo) infusion before bypass
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Time Points of EEG Patterns
Hide Description [Not Specified]
Time Frame Day of surgery through discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed due to study terminated early.
Arm/Group Title Nicardipine 0.9% Saline
Hide Arm/Group Description:

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 (placebo) infusion before bypass
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Time Points for SSEP Latency and Amplitude Changes
Hide Description [Not Specified]
Time Frame Day of surgery through discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed due to study terminated early.
Arm/Group Title Nicardipine 0.9% Saline
Hide Arm/Group Description:

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 (placebo) infusion before bypass
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Bispectral Index Scores (BIS)
Hide Description [Not Specified]
Time Frame Day of surgery through discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed due to study terminated early.
Arm/Group Title Nicardipine 0.9% Saline
Hide Arm/Group Description:

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 (placebo) infusion before bypass
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Cerebral Oximetry Measurements
Hide Description [Not Specified]
Time Frame Day of surgery through discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed due to study terminated early.
Arm/Group Title Nicardipine 0.9% Saline
Hide Arm/Group Description:

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 (placebo) infusion before bypass
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Transcranial Doppler Measurements
Hide Description [Not Specified]
Time Frame Day of surgery through discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed due to study terminated early.
Arm/Group Title Nicardipine 0.9% Saline
Hide Arm/Group Description:

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 (placebo) infusion before bypass
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nicardipine 0.9% Saline
Hide Arm/Group Description Nicardipine infusion before bypass 0.9% saline (placebo) before bypass
All-Cause Mortality
Nicardipine 0.9% Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nicardipine 0.9% Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nicardipine 0.9% Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      0/3 (0.00%)    
Cardiac disorders     
Hypotension   3/3 (100.00%)  3 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
This study was terminated early because of safety concerns in the active treatment group. In 3 patients randomized, the blind was broken in 3 because of refractory hypotension and acidosis requiring vasopressor therapy. All 3 were on active drug.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Andrew Shaw MD
Organization: Duke University Medical Center
Phone: 919 286 6938
Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00508118     History of Changes
Other Study ID Numbers: Pro00001612
First Submitted: July 25, 2007
First Posted: July 27, 2007
Results First Submitted: September 21, 2011
Results First Posted: March 8, 2013
Last Update Posted: August 1, 2014