Effects of Chronic Antihypertensive Therapy on Clinical Outcomes in Septic Shock

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02876341
• Other study ID #: 16081002
• Status: Completed
• Phase: N/A
• First received: August 12, 2016
• Last updated: April 11, 2017
• Start date: August 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: April 2017
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: March 31, 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Septic Shock
• Shock
• Shock, Septic

Locations

Country	Name	City	State
United States	Rush Univeristy Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart rate > 100	Total number of times with heart rate greater than 100 in 48 hours.	48 hours
Secondary	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
Secondary	Peak lactate	Peak lactate level during the first 48 hours of admission	48 hours
Secondary	Duration of mechanical ventilation		During admission
Secondary	In hospital mortality		During admission
Secondary	28 day mortality		28 days after discharge
Secondary	90 day mortality		90 days after discharge
Secondary	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
Secondary	Cumulative percent (%) of patients with new onset atrial fibrillation at 24 hours		24 hours