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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02884011
• Other study ID #: 16081001
• Status: Completed
• Phase: N/A
• First received: August 12, 2016
• Last updated: April 11, 2017
• Start date: August 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: April 2017
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: March 31, 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Locations

Country	Name	City	State
United States	Rush Univeristy Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total vasopressor dose	The primary objective is to determine the effect of chronic ß-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	Cumulative fluid volume	Cumulative fluid volume (mL). Example fluids include, 0.9% normal saline, Plasmalyte A, 0.45% normal saline + 5% dextrose, lactated ringers, etc	48 hours
Secondary	Inotrope use	Cumulative inotrope use at different time points (total mg). Example inotropes include dobutamine and milrinone	6, 12, 24, 48 hours
Secondary	Hydrocortisone use	Cumulative hydrocortisone (mg) use at different time points	6, 12, 24, 48 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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