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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794025
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : June 8, 2016
Sponsor:
Information provided by (Responsible Party):
Xiuling Shang, Fujian Provincial Hospital

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

Condition or disease Intervention/treatment Phase
Severe Sepsis Drug: Esmolol Drug: natural saline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Esmolol on Tissue Perfusion and Clinical Prognosis of Patients With Severe Sepsis: a Prospective Cohort Study .
Study Start Date : January 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Experimental: esmolol group
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

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 Name: β-blockers

Sham Comparator: control group
Control group also received natural saline via a micro pump, in the same way the esmolol group received esmolol.
Drug: natural saline
Control group also received natural saline via a micro pump,




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794025


Sponsors and Collaborators
Fujian Provincial Hospital
Investigators
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Study Director: Rongguo Yu, MD Fujian Provincial Hospital
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Responsible Party: Xiuling Shang, the ethic committee of Fujian Provincial Hospital, Fujian Provincial Hospital
ClinicalTrials.gov Identifier: NCT02794025    
Other Study ID Numbers: K2010-001-01
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 151 patients with severe sepsis were selected and divided into the esmolol group (n = 75) or the control group (n = 76)
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Esmolol
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs