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

Completed

• Conditions: Septic Shock

• Registration Number: NCT02884011
• Lead Sponsor: Rush University Medical Center

Brief Summary

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

• Study Start: 2016-08
• Study First Submitted: 2016-08-12
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-30
• Primary Completion: 2017-02
• Study Completion: 2017-03-31
• Results First Submitted: 2022-06-27
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-11
• Last Update Submitted: 2024-11-11
• Results First Posted: 2025-01-03
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Vasopressor Dose	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 Outcome Measures

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

Trial Locations

Locations (1)

Rush Univeristy Medical Center; 🇺🇸 Chicago, Illinois, United States