Trial · NCT00508118
NICardipine Neuroprotection in AortiC Surgery (NICNACS)
NCT00508118, Phase 2, Terminated, Duke University; results first posted 2013-03-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. NICardipine Neuroprotection in AortiC Surgery (NICNACS). Trials, record NCT00508118. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00508118
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NICardipine Neuroprotection in AortiC Surgery (NICNACS)
- NCT number
- NCT00508118
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Aortic Aneurysm, Thoracic
- Interventions
- Nicardipine, 0.9% saline
- First posted
- 2007-07-27
- Last updated
- 2014-08-01
- Results first posted
- 2013-03-08
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Day of surgery | |
| Secondary | Temperature at Which ECS Occurs | Day of surgery through discharge | |
| Secondary | Temperature at Which Ablation of(SSEP)Occurs | Day of surgery through discharge | |
| Secondary | Time Points of EEG Patterns | Day of surgery through discharge | |
| Secondary | Time Points for SSEP Latency and Amplitude Changes | Day of surgery through discharge | |
| Secondary | Bispectral Index Scores (BIS) | Day of surgery through discharge | |
| Secondary | Cerebral Oximetry Measurements | Day of surgery through discharge | |
| Secondary | Transcranial Doppler Measurements | Day of surgery through discharge |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Day of surgery | 3 SUBJECTS PER PROTOCOL. | Time (minutes) | MEDIAN |
| SECONDARY | Temperature at Which ECS Occurs | Day of surgery through discharge | No participants analyzed due to study terminated early. | ||
| SECONDARY | Temperature at Which Ablation of(SSEP)Occurs | Day of surgery through discharge | No participants were analyzed due to study terminated early. | ||
| SECONDARY | Time Points of EEG Patterns | Day of surgery through discharge | No participants were analyzed due to study terminated early. | ||
| SECONDARY | Time Points for SSEP Latency and Amplitude Changes | Day of surgery through discharge | No participants were analyzed due to study terminated early. | ||
| SECONDARY | Bispectral Index Scores (BIS) | Day of surgery through discharge | No participants were analyzed due to study terminated early. | ||
| SECONDARY | Cerebral Oximetry Measurements | Day of surgery through discharge | No participants were analyzed due to study terminated early. | ||
| SECONDARY | Transcranial Doppler Measurements | Day of surgery through discharge | No participants were analyzed due to study terminated early. |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | NICARDIPINE GROUP | 45 | 95% Confidence Interval 35 to 56 | Time (minutes) |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nicardipine | 3 | |
| Overall Study | STARTED | 0.9% Saline | 4 | |
| Overall Study | COMPLETED | Nicardipine | 3 | |
| Overall Study | COMPLETED | 0.9% Saline | 4 | |
| Overall Study | NOT COMPLETED | Nicardipine | 0 | |
| Overall Study | NOT COMPLETED | 0.9% Saline | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypotension | Cardiac disorders | Nicardipine | 3 | 3 | 3 |
| other | Hypotension | Cardiac disorders | 0.9% Saline | 0 | 3 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nicardipine | ||
| Total, all-cause mortality | 0.9% Saline | ||
| Total, other adverse events | Nicardipine | 3 | 3 |
| Total, other adverse events | 0.9% Saline | 0 | 3 |
| Total, serious adverse events | Nicardipine | 0 | 3 |
| Total, serious adverse events | 0.9% Saline | 0 | 3 |
Source ClinicalTrials.gov
Papers14
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Nicardipine vs 0.9% Saline: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00508118
GET https://conductscience.org/api/trials/v1/NCT00508118/registered