The Effect of Esmolol on Clinical Prognosis of Patients With Severe Sepsis

The purpose of this study was to investigate the effect of esmolol on hemodynamic parameters,tissue perfusion and the clinical prognosis of patients with severe sepsis

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Key information

Conditions

Severe Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

enrollment:151 patients

Inclusion criteria

(1) age > 18 years; (2) severe sepsis (acute organ dysfunction secondary to infection )diagnosis according to Campaign to Save Septic Patients: 2008 Treatment Guidelines for Severe Sepsis and Septic Shock, who (3) mechanical ventilation via endotracheal intubation with a tidal volume of 6 mL/kg; and (4) satisfactory sedation and analgesic treatment, with HR > 100 bpm.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

age > 18 years;
severe sepsis (acute organ dysfunction secondary to infection )diagnosis according to Campaign to Save Septic Patients: 2008 Treatment Guidelines for Severe Sepsis and Septic Shock,
mechanical ventilation via endotracheal intubation with a tidal volume of 6 mL/kg;
satisfactory sedation and analgesic treatment, with HR > 100 bpm.

Exclusion criteria

pre-existing cardiac dysfunction, valvular heart disease, high-degree atrioventricular block;
acute or chronic pulmonary heart disease;
a history of serious asthma;
chronic renal insufficiency;
cancer, autoimmune diseases, or contraindications for placement of deep venous catheter;
insulin-dependent diabetes.

Treatment and study plan

esmolol

Drug

patients in the esmolol group received continuous infusion of esmolol via a micro-pump through a catheter placed in the superior vena cava. The initial dose was 0.05 mg/kg/min and was adjusted based on heart rate (HR) (target HR: 70 bpm < HR < 100 bpm within 72 hours).

Control group also received natural saline via a micro pump, in the same way the esmolol group received esmolol.

Other names: β-blockers

natural saline

Drug

Control group also received natural saline via a micro pump,

Primary outcomes

The survival time of patients more than 28 days is defined as survival. The survival time of patients less than 28 days is defined as death.

Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Fujian Provincial Hospital

Other

Registry information

Official study title

The Effect of Esmolol on Tissue Perfusion and Clinical Prognosis of Patients With Severe Sepsis: a Prospective Cohort Study .

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Jun 8, 2016
Registry last updated: Jun 8, 2016

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.

Published trials that share one or more normalized conditions with this study.

Completed