Trial Outcomes & Findings for Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass (CPB) in Cardiac Surgery (NCT NCT01212874)

Last Updated: 2019-03-01

Results Overview

Area under the curve (AUC) of Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass

Recruitment status

COMPLETED

Study phase

Target enrollment

70 participants

Primary outcome timeframe

Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours

Results posted on

2019-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	Esmolol esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.	Nitroglycerin nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
Overall Study STARTED	35	35
Overall Study Received Allocated Intervention	13	12
Overall Study COMPLETED	13	12
Overall Study NOT COMPLETED	22	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass (CPB) in Cardiac Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nitroglycerin n=35 Participants nitroglycerin infusion titrated to control hypertension from anesthesia induction to initiation of cardiopulmonary bypass nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.	Esmolol n=35 Participants esmolol infusion titrated to control hypertension from anesthesia induction to initiation of cardiopulmonary bypass esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	19 Participants n=7 Participants	42 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Age, Continuous	61.4 years STANDARD_DEVIATION 11.6 • n=5 Participants	61.6 years STANDARD_DEVIATION 13.2 • n=7 Participants	61.5 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants
Body mass index kg/m^2	29.8 kg/m^2 STANDARD_DEVIATION 5.6 • n=5 Participants	29.5 kg/m^2 STANDARD_DEVIATION 7.7 • n=7 Participants	29.6 kg/m^2 STANDARD_DEVIATION 6.7 • n=5 Participants

PRIMARY outcome

Timeframe: Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours

Population: Data capture failure lost data from 2 treated patients in each group; these were thus excluded from analysis.

Area under the curve (AUC) of Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass

Outcome measures

Outcome measures
Measure	Esmolol n=11 Participants esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.	Nitroglycerin n=10 Participants nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour	97.9 mmHg*min/prebypass hour Interval 47.7 to 181.4	45.6 mmHg*min/prebypass hour Interval 21.0 to 93.9

SECONDARY outcome

Timeframe: Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours

Population: Data capture failure lost data from 2 treated patients in each group; these were thus excluded from analysis.

Area under the curve (AUC) of Systolic Blood Pressure Excursions Beyond Predetermined Upper Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass

Outcome measures

Outcome measures
Measure	Esmolol n=11 Participants esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.	Nitroglycerin n=10 Participants nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
Title: Systolic Hypertension	48.6 mmHg*min / prebypass hour Interval 18.2 to 90.8	145.8 mmHg*min / prebypass hour Interval 79.4 to 259.9

Adverse Events

Esmolol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nitroglycerin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Patricia Moore

Loma Linda University Anesthesiology

Phone: 1-909-558-4475

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place