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

Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass(CPB) in Cardiac Surgery: a Randomized, Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01212874
Enrollment
70
Registered
2010-10-01
Start date
2010-12-31
Completion date
2014-06-30
Last updated
2019-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

This is an investigator initiated, sponsored, open label, prospective randomized controlled trial to be performed in adult patients undergoing scheduled cardiac surgery. Patients will be randomized to esmolol infusion or nitroglycerin infusion for control of hypertension that occurs during cardiac surgery from induction of anesthesia to initiation of cardiopulmonary bypass (CPB).

Interventions

DRUGnitroglycerin

nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.

DRUGesmolol

esmolol will be administered by infusion following a step up / step down protocol to control hypertension.

Sponsors

Loma Linda University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* adult patients scheduled for cardiac surgery at LLUMC University Hospital will be eligible for participation in this study.

Exclusion criteria

1. severe LV (left ventricle)dysfunction (EF \< 35%). 2. emergency procedures. 3. procedures with combined carotid artery surgery. 4. patients at high risk for stroke. 5. hemodynamically significant dysrhythmias. 6. pre-existing atrial fibrillation or high degree AV (atrioventricular block). 7. pacemaker dependency. 8. known sensitivity to beta blockers. 9. patient refusal.

Design outcomes

Primary

MeasureTime frameDescription
Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per HourParticipants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hoursArea under the curve (AUC) of Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass

Secondary

MeasureTime frameDescription
Title: Systolic HypertensionParticipants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hoursArea under the curve (AUC) of Systolic Blood Pressure Excursions Beyond Predetermined Upper Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass

Countries

United States

Participant flow

Participants by arm

ArmCount
Nitroglycerin
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.
35
Esmolol
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.
35
Total70

Baseline characteristics

CharacteristicTotalEsmololNitroglycerin
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
28 Participants16 Participants12 Participants
Age, Categorical
Between 18 and 65 years
42 Participants19 Participants23 Participants
Age, Continuous61.5 years
STANDARD_DEVIATION 12.4
61.6 years
STANDARD_DEVIATION 13.2
61.4 years
STANDARD_DEVIATION 11.6
Body mass index kg/m^229.6 kg/m^2
STANDARD_DEVIATION 6.7
29.5 kg/m^2
STANDARD_DEVIATION 7.7
29.8 kg/m^2
STANDARD_DEVIATION 5.6
Region of Enrollment
United States
70 participants35 participants35 participants
Sex: Female, Male
Female
20 Participants10 Participants10 Participants
Sex: Female, Male
Male
50 Participants25 Participants25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 350 / 35
serious
Total, serious adverse events
0 / 350 / 35

Outcome results

Primary

Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour

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

Time frame: 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.

ArmMeasureValue (MEDIAN)
EsmololDiastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour97.9 mmHg*min/prebypass hour
NitroglycerinDiastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour45.6 mmHg*min/prebypass hour
p-value: 0.21t-test, 2 sided
Secondary

Title: Systolic Hypertension

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

Time frame: 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.

ArmMeasureValue (MEDIAN)
EsmololTitle: Systolic Hypertension48.6 mmHg*min / prebypass hour
NitroglycerinTitle: Systolic Hypertension145.8 mmHg*min / prebypass hour
p-value: 0.04t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026