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Heart Rate Control With Esmolol in Septic Shock

Strict Heart Rate Control With Esmolol in Septic Shock: a Randomized, Controlled, Clinical Pilot Study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01231698
Enrollment
154
Registered
2010-11-01
Start date
2010-12-31
Completion date
2012-07-31
Last updated
2013-01-24

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

Conditions

Septic Shock

Keywords

septic shock, esmolol, tachycardia, betablockers

Brief summary

The purpose of this study is investigate the effects on systemic hemodynamics and organ function of esmolol when used to maintain heart rate below a predefined threshold in patients with septic shock.

Detailed description

154 septic shock patients with heart rate \> of 95 bpm and requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation, will be enrolled in the study. Patients will be randomly allocated to be treated with either a) a continuous esmolol infusion at any doses to maintain heart rate between 95 and 80 bpm b)to a standard treatment without heart rate control(control; each n = 77). In both groups, norepinephrine will be titrated to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg. Data from right heart catheterization,data from organ function as well as norepinephrine requirements will be obtained at baseline and after 24, 48, 72, and 96 hours. The protocol will require that esmolol be infused continuously at any doses to maintain the predefined heart rate threshold until one the following events occur: the patient die, a serious adverse effect attributed to the study drug infusion, or the patient has been discharged from ICU.

Interventions

DRUGesmolol

Strict heart rate control: esmolol at any dose to maintain heart rate between 95 and 80 bpm.

OTHERcontrol

standard treatment without strict heart rate control

Sponsors

Andrea Morelli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

* septic shock criteria * presence of heart rate \> 95 bpm.

Exclusion criteria

* Pregnancy * age \< 18

Design outcomes

Primary

MeasureTime frame
heart rateover a period of 96 hrs

Secondary

MeasureTime frameDescription
systemic hemodynamicsover a period of 96 hourssystemic hemodynamics,norepinephrine requirements,organ functions,adverse effects.

Other

MeasureTime frame
ICU Mortality28 days

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026