Clinical trial NCT02876341: Effects of Chronic Antihypertensive Therapy on Clinical Outcomes in Septic Shock
Official title: Evaluating the Effect of Chronic Antihypertensive Therapy on New Onset Atrial Fibrillation and Clinical Outcomes in Septic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Septic Shock
Keywords: Chronic antihypertensives
New onset atrial fibrillation
Septic shock
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult, non pregnant medical intensive care (MICU) patient's with septic shock

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

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

Primary outcomes:
measure: Cumulative percent (%) of patients with new onset atrial fibrillation at 48 hours
timeFrame: 48 hours
Secondary outcomes:
measure: Heart rate > 100
timeFrame: 48 hours
measure: New onset of other arrhythmias
timeFrame: 48 hours
measure: Peak lactate
timeFrame: 48 hours
measure: Duration of mechanical ventilation
timeFrame: During admission
measure: In hospital mortality
timeFrame: During admission
measure: 28 day mortality
timeFrame: 28 days after discharge
measure: 90 day mortality
timeFrame: 90 days after discharge
measure: New onset atrial fibrillation for patients on other antiarrhythmics
timeFrame: 24 and 48 hours
measure: Cumulative percent (%) of patients with new onset atrial fibrillation at 24 hours
timeFrame: 24 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush Univeristy Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Joshua DeMott, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: Ishaq Lat, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: Gourang Patel, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: