Back to resultsThe Effect of Esmolol on Clinical Prognosis of Patients With Severe Sepsis
Primary Purpose
Severe Sepsis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Esmolol
natural saline
Sponsored by
About this trial
This is an interventional treatment trial for Severe Sepsis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
esmolol group
control group
Arm Description
patients in the esmolol group received continuous infusion of esmolol via a micro-pump through a catheter placed in the superior vena cava.
Control group also received natural saline via a micro pump, in the same way the esmolol group received esmolol.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02794025
Brief Title
The Effect of Esmolol on Clinical Prognosis of Patients With Severe Sepsis
Official Title
The Effect of Esmolol on Tissue Perfusion and Clinical Prognosis of Patients With Severe Sepsis: a Prospective Cohort Study .
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Provincial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
esmolol group
Arm Type
Experimental
Arm Description
patients in the esmolol group received continuous infusion of esmolol via a micro-pump through a catheter placed in the superior vena cava.
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
Control group also received natural saline via a micro pump, in the same way the esmolol group received esmolol.
Intervention Type
Drug
Intervention Name(s)
Esmolol
Other Intervention Name(s)
β-blockers
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
natural saline
Intervention Description
Control group also received natural saline via a micro pump,
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongguo Yu, MD
Organizational Affiliation
Fujian Provincial Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
151 patients with severe sepsis were selected and divided into the esmolol group (n = 75) or the control group (n = 76)
Learn more about this trial
The Effect of Esmolol on Clinical Prognosis of Patients With Severe Sepsis
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