Effects of Chronic Antihypertensive Therapy on Clinical Outcomes in Septic Shock

Evaluating the Effect of Chronic Antihypertensive Therapy on New Onset Atrial Fibrillation and Clinical Outcomes in Septic Shock

Retrospective two-cohort study to determine the effect of chronic antihypertensive therapy on new onset atrial fibrillation and clinical outcomes in septic shock.

Study Overview

• Status: Completed
• Conditions: Septic Shock; Atrial Fibrillation

Detailed Description

This will be a retrospective two-cohort study to determine the effect of chronic antihypertensive therapy on new onset atrial fibrillation and clinical outcomes in septic shock. The two cohorts will be septic shock patients that were: 1) not on either a chronic β-blocker or angiotensin-converting-enzyme inhibitor (ACE inhibitor) or 2) on a chronic β-blocker, on chronic ACE-Inhibitor, or 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
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult, non pregnant medical intensive care (MICU) patient's with septic shock

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 the medical intensive care unit (MICU) 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 to MICU in cardiopulmonary arrest
• Prior arrest within 24 hours of admission to RUMC

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
No chronic antihypertensives; Not on either a chronic β-blocker or ACE-Inhibitor
Chronic antihypertensives; On a chronic β-blocker, on chronic ACE-Inhibitor, or on both chronic β-blocker and ACE-inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative percent (%) of patients with new onset atrial fibrillation at 48 hours	New onset atrial fibrillation defined as atrial fibrillation not present on admission to MICU	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate > 100	Total number of times with heart rate greater than 100 in 48 hours.	48 hours
New onset of other arrhythmias	Total onset of other arrhythmias not present on admission. Examples include, ventricular fibrillation, ventricular tachycardia, heart blocks, etc	48 hours
Peak lactate	Peak lactate level during the first 48 hours of admission	48 hours
Duration of mechanical ventilation		During admission
In hospital mortality		During admission
28 day mortality		28 days after discharge
90 day mortality		90 days after discharge
New onset atrial fibrillation for patients on other antiarrhythmics	Antiarrhythmic agents that are used to suppress abnormal rhythms of the heart (cardiac arrhythmias), such as atrial fibrillation, atrial flutter, ventricular tachycardia, and ventricular fibrillation. Will include any single or combination of class I, II, III, IV antiarrhythmic agents	24 and 48 hours
Cumulative percent (%) of patients with new onset atrial fibrillation at 24 hours		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 (Actual): 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 18, 2016
• First Posted (Estimate): August 23, 2016

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Septic shock; New onset atrial fibrillation; Chronic antihypertensives
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Arrhythmias, Cardiac; Shock, Septic; Atrial Fibrillation; Shock
• Other Study ID Numbers: 16081002

Plan for Individual participant data (IPD)

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