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Completed

NCT Number: NCT02884011

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

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rush Univeristy Medical Center

Chicago, Illinois, 60612, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 30 mL/kg Fluid Within 6h

    Time frame: 48 hours

    Number of Participants with 30 mL/kg Fluid Within 6 Hours

  2. Inotrope Use

    Time frame: 6, 12, 24, 48 hours

    Cumulative inotrope use at different time points (total mg). Example inotropes include dobutamine and milrinone

  3. Hydrocortisone Use

    Time frame: 6, 12, 24, 48 hours

    Cumulative hydrocortisone (mg) use at different time points

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 30, 2016
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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