Effects of Chronic Antihypertensive Therapy on Clinical Outcomes in Septic Shock

Overview

Retrospective two-cohort study to determine the effect of chronic antihypertensive therapy on new onset atrial fibrillation and clinical outcomes in septic shock.

Full Title of Study: “Evaluating the Effect of Chronic Antihypertensive Therapy on New Onset Atrial Fibrillation and Clinical Outcomes in Septic Shock”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: February 2017

Detailed Description

This will be a retrospective two-cohort study to determine the effect of chronic antihypertensive therapy on new onset atrial fibrillation and clinical outcomes in septic shock. The two cohorts will be septic shock patients that were: 1) not on either a chronic β-blocker or angiotensin-converting-enzyme inhibitor (ACE inhibitor) or 2) on a chronic β-blocker, on chronic ACE-Inhibitor, or on both chronic β-blocker and ACE-inhibitor

Arms, Groups and Cohorts

  • No chronic antihypertensives
    • Not on either a chronic β-blocker or ACE-Inhibitor
  • Chronic antihypertensives
    • On a chronic β-blocker, on chronic ACE-Inhibitor, or on both chronic β-blocker and ACE-inhibitor

Clinical Trial Outcome Measures

Primary Measures

  • Cumulative percent (%) of patients with new onset atrial fibrillation at 48 hours
    • Time Frame: 48 hours
    • New onset atrial fibrillation defined as atrial fibrillation not present on admission to MICU

Secondary Measures

  • Heart rate > 100
    • Time Frame: 48 hours
    • Total number of times with heart rate greater than 100 in 48 hours.
  • New onset of other arrhythmias
    • Time Frame: 48 hours
    • Total onset of other arrhythmias not present on admission. Examples include, ventricular fibrillation, ventricular tachycardia, heart blocks, etc
  • Peak lactate
    • Time Frame: 48 hours
    • Peak lactate level during the first 48 hours of admission
  • Duration of mechanical ventilation
    • Time Frame: During admission
  • In hospital mortality
    • Time Frame: During admission
  • 28 day mortality
    • Time Frame: 28 days after discharge
  • 90 day mortality
    • Time Frame: 90 days after discharge
  • New onset atrial fibrillation for patients on other antiarrhythmics
    • Time Frame: 24 and 48 hours
    • Antiarrhythmic agents that are used to suppress abnormal rhythms of the heart (cardiac arrhythmias), such as atrial fibrillation, atrial flutter, ventricular tachycardia, and ventricular fibrillation. Will include any single or combination of class I, II, III, IV antiarrhythmic agents
  • Cumulative percent (%) of patients with new onset atrial fibrillation at 24 hours
    • Time Frame: 24 hours

Participating in This Clinical Trial

Inclusion Criteria

  • Adult patients 18 years of age or older – Diagnosis of septic shock requiring vasopressor therapy (norepinephrine, epinephrine, phenylephrine, dopamine, or vasopressin) – Admitted to the medical intensive care unit (MICU) at Rush University Medical Center (RUMC) – Time frame: 01/01/2012 to 07/1/2016 Exclusion Criteria:

  • Pregnant patients – Transfer from outside hospital on vasopressors – Admitted to MICU in cardiopulmonary arrest – Prior arrest within 24 hours of admission to RUMC

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rush University Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joshua DeMott, Pharm.D., Principal Investigator, Rush University Medical Center
    • Ishaq Lat, Pharm.D., Principal Investigator, Rush University Medical Center
    • Gourang Patel, Pharm.D., Principal Investigator, Rush University Medical Center

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