Atrial FibrillationNCT02876341
Effects of Chronic Antihypertensive Therapy on Clinical Outcomes in Septic Shock
An observational study of Atrial Fibrillation and Septic Shock, run by Rush University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Septic Shock
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 31 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult, non pregnant medical intensive care (MICU) patient's with septic shock
Who may be able to join
- 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
Who cannot join
- Pregnant patients
- Transfer from outside hospital on vasopressors
- Admitted to MICU in cardiopulmonary arrest
- Prior arrest within 24 hours of admission to RUMC
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush Univeristy Medical Center
Chicago, Illinois, 60612
About this study
Official title: Evaluating the Effect of Chronic Antihypertensive Therapy on New Onset Atrial Fibrillation and 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.
Read the 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
- Conditions
- Atrial Fibrillation, Septic Shock
- Keywords
- Chronic antihypertensives, New onset atrial fibrillation, Septic shock
- Medical subject headings
- Atrial Fibrillation, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No chronic antihypertensives | Not on either a chronic β-blocker or ACE-Inhibitor | |
| Chronic antihypertensives | On a chronic β-blocker, on chronic ACE-Inhibitor, or on both chronic β-blocker and ACE-inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Secondary outcomes (9)
Heart rate > 100
Total number of times with heart rate greater than 100 in 48 hours.
Measured: 48 hours
New onset of other arrhythmias
Total onset of other arrhythmias not present on admission. Examples include, ventricular fibrillation, ventricular tachycardia, heart blocks, etc
Measured: 48 hours
Peak lactate
Peak lactate level during the first 48 hours of admission
Measured: 48 hours
Duration of mechanical ventilation
Measured: During admission
In hospital mortality
Measured: During admission
28 day mortality
Measured: 28 days after discharge
90 day mortality
Measured: 90 days after discharge
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
Measured: 24 and 48 hours
Cumulative percent (%) of patients with new onset atrial fibrillation at 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua DeMott, Pharm.D., Principal investigator, Rush University Medical CenterIshaq Lat, Pharm.D., Principal investigator, Rush University Medical CenterGourang Patel, Pharm.D., Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876341
- Sponsor's protocol ID
- 16081002
- Status last verified
- Apr 2017
- First submitted
- 12 Aug 2016
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: To be determined
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Chronic Antihypertensive Therapy on New Onset Atrial Fibrillation and Clinical Outcomes in Septic Shock
- ClinicalTrials.gov ID
- NCT02876341
- Acronym / sponsor ID
- 16081002
- Conditions
- Atrial Fibrillation, Septic Shock
- Keywords
- Chronic antihypertensives, New onset atrial fibrillation, Septic shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No chronic antihypertensives | – | –Not on either a chronic β-blocker or ACE-Inhibitor |
| Chronic antihypertensives | – | –On a chronic β-blocker, on chronic ACE-Inhibitor, or on both chronic β-blocker and ACE-inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, non pregnant medical intensive care (MICU) patient's with septic shock
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant patients
- Transfer from outside hospital on vasopressors
- Admitted to MICU in cardiopulmonary arrest
- Prior arrest within 24 hours of admission to RUMC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Individual participant dataSharing planned: Undecided. To be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua DeMott, Pharm.D. principal investigator
Rush University Medical Center
Ishaq Lat, Pharm.D. principal investigator
Rush University Medical Center
Gourang Patel, Pharm.D. principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Septic Shock, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative percent (%) of patients with new onset atrial fibrillation at 48 hours (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.