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Completed

NCT Number: NCT01231698

Heart Rate Control With Esmolol in Septic Shock

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.

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Key information

Conditions

Septic Shock Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Anesthesiology and Intensive care of the University of Rome La Sapienza

Rome, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • septic shock criteria
  • presence of heart rate > 95 bpm.

Exclusion criteria

  • Pregnancy
  • age < 18

Treatment and study plan

esmolol

Drug

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

Control

Other

standard treatment without strict heart rate control

Primary outcomes

  1. heart rate

    Time frame: over a period of 96 hrs

Secondary outcomes

  1. systemic hemodynamics

    Time frame: over a period of 96 hours

    systemic hemodynamics,norepinephrine requirements,organ functions,adverse effects.

Other outcomes

  1. ICU Mortality

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Andrea Morelli

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 1, 2010
Registry last updated
Jan 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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