Evaluating the Effect of Chronic Antihypertensive Therapy on Vasopressor Dosing in Septic Shock

Overview

Retrospective study to examine the effects of chronic antihypertensive medications on vasopressor dosing 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 four-cohort study. The four cohorts will be septic shock patients that were: 1) not on either a chronic β-blocker or chronic angiotensin-converting-enzyme inhibitor (ACE-Inhibitor), 2) on chronic β-blocker, 3) on ACE-Inhibitor, and 4) 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
  • β-blocker
    • on chronic β-blocker
  • ACE-Inhibitor
    • on chronic ACE-Inhibitor
  • Both β-blocker and ACE-inhibitor
    • on both chronic β-blocker and ACE-inhibitor

Clinical Trial Outcome Measures

Primary Measures

  • Total vasopressor dose
    • Time Frame: 48 hours
    • The primary objective is to determine the effect of chronic β-blocker or ACE-inhibitor on vasopressor dosing in the first 48 hours of septic shock. Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine

Secondary Measures

  • Cumulative fluid volume
    • Time Frame: 48 hours
    • Cumulative fluid volume (mL). Example fluids include, 0.9% normal saline, Plasmalyte A, 0.45% normal saline + 5% dextrose, lactated ringers, etc
  • Inotrope use
    • Time Frame: 6, 12, 24, 48 hours
    • Cumulative inotrope use at different time points (total mg). Example inotropes include dobutamine and milrinone
  • Hydrocortisone use
    • Time Frame: 6, 12, 24, 48 hours
    • Cumulative hydrocortisone (mg) use at different time points
  • Cumulative vasopressor dose for patients receiving other antihypertensives
    • Time Frame: 6, 12, 24, 48 hours
    • To determine cumulative vasopressor dose at various time points of patients on chronic calcium channel blocker or other antihypertensives (i.e., hydralazine, clonidine, angiotensin-receptor-blocker (ARB), etc). Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine
  • 6-hour vasopressor dose
    • Time Frame: 6 hours
    • Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine
  • 12-hour vasopressor dose
    • Time Frame: 12 hours
    • Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine
  • 24-hour vasopressor dose
    • Time Frame: 24 hours
    • Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine

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 an intensive care unit (ICU) 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 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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