Effects of Chronic Antihypertensive Therapy on Clinical Outcomes in Septic Shock

Completed

• Conditions: Atrial Fibrillation; Septic Shock

• Registration Number: NCT02876341
• Lead Sponsor: Rush University Medical Center

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

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-12
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-23
• Primary Completion: 2017-02
• Study Completion: 2017-03-31
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-13

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 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	During admission
In hospital mortality	During admission
Heart rate > 100	48 hours	Total number of times with heart rate greater than 100 in 48 hours.
New onset of other arrhythmias	48 hours	Total onset of other arrhythmias not present on admission. Examples include, ventricular fibrillation, ventricular tachycardia, heart blocks, etc
Peak lactate	48 hours	Peak lactate level during the first 48 hours of admission
28 day mortality	28 days after discharge
New onset atrial fibrillation for patients on other antiarrhythmics	24 and 48 hours	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
Cumulative percent (%) of patients with new onset atrial fibrillation at 24 hours	24 hours
90 day mortality	90 days after discharge

Trial Locations

Locations (1)

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