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Completed

NCT Number: NCT02876341

Effects of Chronic Antihypertensive Therapy on Clinical Outcomes in Septic Shock

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rush Univeristy Medical Center

Chicago, Illinois, 60612, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cumulative percent (%) of patients with new onset atrial fibrillation at 48 hours

    Time frame: 48 hours

    New onset atrial fibrillation defined as atrial fibrillation not present on admission to MICU

Secondary outcomes

  1. Heart rate > 100

    Time frame: 48 hours

    Total number of times with heart rate greater than 100 in 48 hours.

  2. New onset of other arrhythmias

    Time frame: 48 hours

    Total onset of other arrhythmias not present on admission. Examples include, ventricular fibrillation, ventricular tachycardia, heart blocks, etc

  3. Peak lactate

    Time frame: 48 hours

    Peak lactate level during the first 48 hours of admission

  4. Duration of mechanical ventilation

    Time frame: During admission

  5. In hospital mortality

    Time frame: During admission

  6. 28 day mortality

    Time frame: 28 days after discharge

  7. 90 day mortality

    Time frame: 90 days after discharge

  8. New onset atrial fibrillation for patients on other antiarrhythmics

    Time frame: 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

  9. Cumulative percent (%) of patients with new onset atrial fibrillation at 24 hours

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 23, 2016
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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