Overview

This trial is active, not recruiting.

Conditions atrial fibrillation, septic shock
Sponsor Rush University Medical Center
Start date August 2016
End date January 2017
Trial size 200 participants
Trial identifier NCT02876341, 16081002

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Not on either a chronic β-blocker or ACE-Inhibitor
On a chronic β-blocker, on chronic ACE-Inhibitor, or on both chronic β-blocker and ACE-inhibitor

Primary Outcomes

Measure
Cumulative percent (%) of patients with new onset atrial fibrillation at 48 hours
time frame: 48 hours

Secondary Outcomes

Measure
Heart rate > 100
time frame: 48 hours
New onset of other arrhythmias
time frame: 48 hours
Peak lactate
time frame: 48 hours
Duration of mechanical ventilation
time frame: During admission
In hospital mortality
time frame: During admission
28 day mortality
time frame: 28 days after discharge
90 day mortality
time frame: 90 days after discharge
New onset atrial fibrillation for patients on other antiarrhythmics
time frame: 24 and 48 hours
Cumulative percent (%) of patients with new onset atrial fibrillation at 24 hours
time frame: 24 hours

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Evaluating the Effect of Chronic Antihypertensive Therapy on New Onset Atrial Fibrillation and Clinical Outcomes in Septic Shock
Principal investigator Joshua DeMott, Pharm.D.
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Rush University Medical Center.