Trial · NCT00799604
Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT)
NCT00799604, Phase 2, Completed, The Medicines Company; results first posted 2014-06-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT). Trials, record NCT00799604. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00799604
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT)
- NCT number
- NCT00799604
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- The Medicines Company
- Conditions
- Hypertension
- Interventions
- clevidipine
- First posted
- 2008-12-01
- Last updated
- 2014-08-29
- Results first posted
- 2014-06-04
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Mean Maximum Absolute Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). | From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia). | Blood Pressure was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as, 'median of all measurements prior to or at the start of Bolus 1'. Locally weighted scatterplot smoothing (LOWESS) method was used to determine the minimum SBP value for each patient. Maximum absolute change is the minimum SBP value within 15 minutes from bolus 1 minus baseline value. |
| Primary | The Mean Maximum Percent Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). | From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia). | Blood Pressure was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as, 'median of all measurements prior to or at the start of Bolus 1'. Locally weighted scatterplot smoothing (LOWESS) method was used to determine the minimum SBP value for each patient. Maximum percent change is defined as the maximum absolute change divided by the baseline value of bolus 1 and multiplied by 100. |
| Secondary | The Percentage of Patients With Systolic Blood Pressure ≤85 mm Hg Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). | From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia). | The percentage is calculated using the number of patients with a systolic blood pressure ≤85 mm Hg within 15 minutes from the initial Bolus 1 dose divided by the total number of patients who were treated with a Bolus 1 clevidipine, and multiplied by 100. |
| Secondary | The Median Time to 5%, 10%, and 15% Systolic Blood Pressure Reduction From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 -Pre-anesthesia). | From start to 15 minutes of Bolus 1 of clevidipine (pre-anesthesia). | BP was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of bolus 1 is defined as median of all measurements prior to or at the start of Bolus 1. The time at which first target SBP reduction (ex. 5%) from baseline was reached was identified for each patient using fitted values from LOWESS method. Kaplan-Meier method was used to estimate the median time. Patients who never reached 5%, 10% or 15% reduction, withdrew from study or changed antihypertensive within 15 minutes were censored. |
| Secondary | The Mean Percent Change in Systolic Blood Pressure From Baseline Over Time During the First 15 Minutes Following First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). | From start to 15 minutes of Bolus 1 of clevidipine (pre-anesthesia). | BP was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as median of all measurements prior to or at the start of Bolus 1. SBP change (percent change) from baseline is calculated at each collection time point after bolus 1 dose for each patient. |
| Secondary | The Median Time to 50%, and, When Available, 90% Recovery From Maximum SBP Effect Following the First Bolus Dose of Clevidipine for Patients Who Achieved the Endpoints (Treatment Period 1, Bolus 1 - Pre-anesthesia). | Up to 15 minutes following the first bolus dose of clevidipine (pre-anesthesia). | Analysis is of the time in minutes between the recorded time at the maximum absolute change and the time of the systolic blood pressure value at the first 50% recovery. The 50% recovery value is equal to the minimum recorded systolic blood pressure value plus 50% of the maximum amount of systolic blood pressure reduction (the Bolus 1 baseline value minus the value at the maximum absolute change). |
| Secondary | Change in Heart Rate After Bolus 1 (Pre-anesthesia). | Baseline up until the first 15 minutes following Bolus 1 (pre-anesthesia). | The baseline heart rate was measured as the median of all the heart rate measurements within 60 seconds or at the start of the administration of Bolus 1. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Mean Maximum Absolute Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). | From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia). | Modified Intent-to-Treat (mITT) population: all enrolled patients who were deemed eligible for the study by meeting all inclusion and no exclusion criteria and were treated with clevidipine. The mITT population is the primary population for the analyses of efficacy. | mm Hg | MEAN |
| SECONDARY | The Percentage of Patients With Systolic Blood Pressure ≤85 mm Hg Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). | From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia). | Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy. | percent patients | NUMBER |
| SECONDARY | The Median Time to 5%, 10%, and 15% Systolic Blood Pressure Reduction From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 -Pre-anesthesia). | From start to 15 minutes of Bolus 1 of clevidipine (pre-anesthesia). | Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy. | minutes | MEDIAN |
| SECONDARY | The Mean Percent Change in Systolic Blood Pressure From Baseline Over Time During the First 15 Minutes Following First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). | From start to 15 minutes of Bolus 1 of clevidipine (pre-anesthesia). | Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy. | percent change | MEAN |
| SECONDARY | The Median Time to 50%, and, When Available, 90% Recovery From Maximum SBP Effect Following the First Bolus Dose of Clevidipine for Patients Who Achieved the Endpoints (Treatment Period 1, Bolus 1 - Pre-anesthesia). | Up to 15 minutes following the first bolus dose of clevidipine (pre-anesthesia). | Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy. | minutes | MEDIAN |
| SECONDARY | Change in Heart Rate After Bolus 1 (Pre-anesthesia). | Baseline up until the first 15 minutes following Bolus 1 (pre-anesthesia). | Safety population: all enrolled patients (irrespective of eligibility) who are dosed with clevidipine. The safety population will be the primary population used for the safety analyses. | beats per minute (bpm) | MEAN |
| PRIMARY | The Mean Maximum Percent Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). | From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia). | Modified Intent-to-Treat (mITT) population: all enrolled patients who were deemed eligible for the study by meeting all inclusion and no exclusion criteria and were treated with clevidipine. The mITT population is the primary population for the analyses of efficacy. | percent change | MEAN |
Source ClinicalTrials.gov
Results by group57
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Mean Maximum Absolute Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). | Cohort 1: Clevidipine 250 μg (0.5 mL) | -18.8 | Standard Deviation 6.51 | mm Hg | |
| The Mean Maximum Absolute Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). | Cohort 2: Clevidipine 500 μg (1.0 mL) | -37.0 | Standard Deviation 17.76 | mm Hg | |
| The Mean Maximum Absolute Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). | Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL of a 1:1 Sol) | -15.8 | Standard Deviation 11.43 | mm Hg | |
| The Percentage of Patients With Systolic Blood Pressure ≤85 mm Hg Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). | Cohort 1: Clevidipine 250 μg (0.5 mL) | 0 | 95% Confidence Interval 0 to 0 | percent patients | |
| The Percentage of Patients With Systolic Blood Pressure ≤85 mm Hg Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). | Cohort 2: Clevidipine 500 μg (1.0 mL) | 0 | 95% Confidence Interval 0 to 0 | percent patients | |
| The Percentage of Patients With Systolic Blood Pressure ≤85 mm Hg Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia). | Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL) | 0 | 95% Confidence Interval 0 to 0 | percent patients | |
| The Median Time to 5%, 10%, and 15% Systolic Blood Pressure Reduction From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 -Pre-anesthesia). | Cohort 1: Clevidipine 250 μg (0.5 mL) | 5 % Reduction | 0.9 | 95% Confidence Interval 0.8 to 1.4 | minutes |
| The Median Time to 5%, 10%, and 15% Systolic Blood Pressure Reduction From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 -Pre-anesthesia). | Cohort 2: Clevidipine 500 μg (1.0 mL) | 5 % Reduction | 0.8 | 95% Confidence Interval 0.2 to 1.3 | minutes |
| The Median Time to 5%, 10%, and 15% Systolic Blood Pressure Reduction From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 -Pre-anesthesia). | Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL) | 5 % Reduction | 1.0 | 95% Confidence Interval 0.7 to NA | minutes |
| The Median Time to 5%, 10%, and 15% Systolic Blood Pressure Reduction From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 -Pre-anesthesia). | Cohort 1: Clevidipine 250 μg (0.5 mL) | 10% Reduction | 1.3 | 95% Confidence Interval 1.0 to NA | minutes |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Bolus 1 (Pre-anesthesia) | STARTED | Planned Cohort 1: Clevidipine 250 μg (0.5 mL) | 10 | |
| Bolus 1 (Pre-anesthesia) | STARTED | Planned Cohort 2: Clevidipine 500 μg (1.0 mL) | 10 | |
| Bolus 1 (Pre-anesthesia) | STARTED | Planned Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5mL Sol) | 10 | |
| Bolus 1 (Pre-anesthesia) | COMPLETED | Planned Cohort 1: Clevidipine 250 μg (0.5 mL) | 10 | |
| Bolus 1 (Pre-anesthesia) | COMPLETED | Planned Cohort 2: Clevidipine 500 μg (1.0 mL) | 10 | |
| Bolus 1 (Pre-anesthesia) | COMPLETED | Planned Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5mL Sol) | 10 | |
| Bolus 1 (Pre-anesthesia) | NOT COMPLETED | Planned Cohort 1: Clevidipine 250 μg (0.5 mL) | 0 | |
| Bolus 1 (Pre-anesthesia) | NOT COMPLETED | Planned Cohort 2: Clevidipine 500 μg (1.0 mL) | 0 | |
| Bolus 1 (Pre-anesthesia) | NOT COMPLETED | Planned Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5mL Sol) | 0 | |
| Bolus 2 (With Anesthesia) | STARTED | Planned Cohort 1: Clevidipine 250 μg (0.5 mL) | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events4
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 | Acidosis | Metabolism and nutrition disorders | All Participants Across All Cohorts and Treatment Periods | 4 | 30 | |
| other | Atelectasis | Respiratory, thoracic and mediastinal disorders | All Participants Across All Cohorts and Treatment Periods | 4 | 30 | |
| other | Hypotension | Vascular disorders | All Participants Across All Cohorts and Treatment Periods | 4 | 30 | |
| serious | Encephalopathy | Nervous system disorders | All Participants Across All Cohorts and Treatment Periods | 1 | 30 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants Across All Cohorts and Treatment Periods | ||
| Total, other adverse events | All Participants Across All Cohorts and Treatment Periods | 12 | 30 |
| Total, serious adverse events | All Participants Across All Cohorts and Treatment Periods | 1 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00799604
GET https://conductscience.org/api/trials/v1/NCT00799604/results?page=2