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

NCT02884011 | Completed Results

• 1 other identifier: 16081001
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Septic Shock

Keywords

Chronic antihypertensives; Septic shock; Vasopressor; Vasopressor dosing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 30 mL/kg Fluid Within 6h

  48 hours

• Inotrope Use

  6, 12, 24, 48 hours

• Hydrocortisone Use

  6, 12, 24, 48 hours

• Cumulative Vasopressor Dose for Patients Receiving Other Antihypertensives

  6, 12, 24, 48 hours

• 6-hour Vasopressor Dose

  6 hours

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Pregnant patients
• Transfer from outside hospital on vasopressors
• Admitted in cardiopulmonary arrest
• Prior arrest within 24 hours of admission to RUMC

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush Univeristy Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Adherence to prescribed chronic β-blockers or ACE inhibitors could not be confirmed. The electronic medical record charting by the staff may be subject to inaccuracies in vasopressor dose infusion changes and documentation. Small sample size.

Results Point of Contact

• Title: Joshua DeMott
• Organization: Rush University Medical Center

joshua_demott@rush.edu

312-947-0226

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 30, 2016
• Study Start: August 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: March 31, 2017
• Last Updated: January 3, 2025
• Results First Posted: January 3, 2025

Record last verified: 2024-11

Locations

US (1)