Effects of Chronic Antihypertensive Therapy on Clinical Outcomes in Septic Shock

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

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

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

Conditions
-----------------
Atrial Fibrillation, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No chronic antihypertensives<br>Not on either a chronic β-blocker or ACE-Inhibitor | |
| Chronic antihypertensives<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic antihypertensives, New onset atrial fibrillation, Septic shock