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

Severe Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794025
• Other study ID #: K2010-001-01
• Status: Completed
• Phase: N/A
• First received: June 4, 2016
• Last updated: June 7, 2016
• Start date: January 2010
• Est. completion date: January 2013

Study information

• Verified date: June 2016
• Source: Fujian Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Fujian Province
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis

Intervention

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.
• natural saline
Control group also received natural saline via a micro pump,

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Provincial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No