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

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

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

Conditions
-----------------
Severe Sepsis

Intervention / Treatment
-----------------
* Drug: Esmolol
* Drug: natural saline


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: esmolol group<br>patients in the esmolol group received continuous infusion of esmolol via a micro-pump through a catheter placed in the superior vena cava. | Drug: Esmolol<br>* 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.<br>* Other names: β-blockers;|
| Sham Comparator: control group<br>Control group also received natural saline via a micro pump, in the same way the esmolol group received esmolol. | Drug: natural saline<br>* Control group also received natural saline via a micro pump,<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 28 days |