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

Retrospective study to examine the effects of chronic antihypertensive medications on vasopressor dosing in septic shock

Study Overview

• Status: Completed
• Conditions: Septic Shock

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

• Study Type: Observational
• Enrollment (Actual): 133

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush Univeristy Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult, non-pregnant medical intensive care unite (MICU) patients with septic shock requiring vasopressor support

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Vasopressor Dose	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	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 mL/kg Fluid Within 6h	Number of Participants with 30 mL/kg Fluid Within 6 Hours	48 hours
Inotrope Use	Cumulative inotrope use at different time points (total mg). Example inotropes include dobutamine and milrinone	6, 12, 24, 48 hours
Hydrocortisone Use	Cumulative hydrocortisone (mg) use at different time points	6, 12, 24, 48 hours
Cumulative Vasopressor Dose for Patients Receiving Other Antihypertensives	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, 12, 24, 48 hours
6-hour Vasopressor Dose	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 hours
12-hour Vasopressor Dose	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 hours
24-hour Vasopressor Dose	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 hours

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Joshua DeMott, Pharm.D., Rush University Medical Center; Principal Investigator: Ishaq Lat, Pharm.D., Rush University Medical Center; Principal Investigator: Gourang Patel, Pharm.D., Rush University Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): March 31, 2017

Study Registration Dates

• First Submitted: August 12, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimated): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Septic shock; Vasopressor; Chronic antihypertensives; Vasopressor dosing
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Shock, Septic
• Other Study ID Numbers: 16081001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: To be determined