Impact of Tachycardia on Outcome After Subarachnoid Hemorrhage (SAH)
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Purpose
The purpose of this retrospective study is to test the hypothesis that uncontrolled tachycardia serves as a risk factor for adverse cardiovascular events and poor outcome after Subarachnoid Hemorrhage (SAH).
| Condition |
|---|
|
Subarachnoid Hemorrhage (SAH) Tachycardia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Impact of Prolonged Tachycardia on Cardiovascular Morbidity and Outcome After Subarachnoid Hemorrhage (SAH) |
- modified Rankin Scale (mRS) score [ Time Frame: Three months ] [ Designated as safety issue: No ]
- Major Adverse Cardiovascular events (MACE) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- pulmonary edema,
- severe hypertension or
- hypotension requiring IV infusion therapy,
- myocardial infarction, and
- serious cardiac arrhythmias including sudden cardiac arrest.
- length of ICU and hospital stay for patients with and without uncontrolled tachycardia
| Estimated Enrollment: | 400 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Subarachnoid Hemorrhage patients
SAH patients with hourly eMR values of Heart Rate
|
Detailed Description:
The design of the current study will be to conduct a retrospective analysis of prolonged heart rate and uncontrolled tachycardia using patients enrolled in the investigators prospective observational cohort study since the electronic medical record systems have been implemented. The investigators know that there have been periods when these electronic systems have failed, resulting in lost data. The investigators anticipate retrospective collection of hourly heart rate for approximately 400 SAH patients that will have ICU data and 3 month modified Rankin documented in our Subarachnoid Hemorrhage Outcomes Project (SHOP) database. The investigators will determine what percent of them have prolonged elevated heart rate and tachycardia. Prolonged heart rate and uncontrolled tachycardia has been defined as a heart rate greater than 95 for greater than 12 hours in one 24 hour period of their ICU stay. The investigators will conduct a ROC curve analysis to determine the appropriate heart rate and duration thresholds that are most predictive of poor prognosis after SAH. Patients be will stratified based on several criteria including admission coma score, early (SAH day 0 to 3) or late (SAH day >=4) ICU admission, presence of intraventricular hemorrhage on admission CT, history of beta-blocker usage, age, and gender.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients admitted to the Columbia Neurocritical Care Unit with a diagnosis of subarachnoid hemorrhage established by computed tomography (CT scan) or xanthochromia of the cerebrospinal fluid if the CT is negative.
Inclusion Criteria:
- Age >=18 years
- Diagnosis of subarachnoid hemorrhage established by computed tomography (CT scan) or xanthochromia of the cerebrospinal fluid if the CT is negative
- Written informed consent from either the patient or a family member
- Admitted to the NICU for at least 12 hours
Exclusion Criteria:
- Age < 18yrs
- traumatic SAH
- SAH due to a rupture of an arteriovenous malformation, neoplasm vasculitis or other secondary causes
Contacts and Locations| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Stephan A Mayer, MD | Columbia University |
| Study Director: | J. Michael Schmidt, PhD | Columbia University |
More Information
No publications provided
| Responsible Party: | Stephan A. Mayer, Professor of Neurology, Columbia University |
| ClinicalTrials.gov Identifier: | NCT01585311 History of Changes |
| Other Study ID Numbers: | AAAA5384 |
| Study First Received: | April 24, 2012 |
| Last Updated: | April 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Columbia University:
|
Subarachnoid Hemorrhage (SAH) tachycardia Outcome |
Additional relevant MeSH terms:
|
Hemorrhage Subarachnoid Hemorrhage Tachycardia Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Arrhythmias, Cardiac Heart Diseases |
ClinicalTrials.gov processed this record on May 21, 2013