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Impact of Tachycardia on Outcome After Subarachnoid Hemorrhage (SAH)

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ClinicalTrials.gov Identifier: NCT01585311
Recruitment Status : Unknown
Verified April 2012 by Stephan A. Mayer, Columbia University.
Recruitment status was:  Enrolling by invitation
First Posted : April 25, 2012
Last Update Posted : April 25, 2012
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Stephan A. Mayer, Columbia University

Brief Summary:
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 or disease
Subarachnoid Hemorrhage (SAH) Tachycardia

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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Prolonged Tachycardia on Cardiovascular Morbidity and Outcome After Subarachnoid Hemorrhage (SAH)
Study Start Date : April 2012
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort
Subarachnoid Hemorrhage patients
SAH patients with hourly eMR values of Heart Rate



Primary Outcome Measures :
  1. modified Rankin Scale (mRS) score [ Time Frame: Three months ]

Secondary Outcome Measures :
  1. Major Adverse Cardiovascular events (MACE) [ Time Frame: 3 months ]
    1. pulmonary edema,
    2. severe hypertension or
    3. hypotension requiring IV infusion therapy,
    4. myocardial infarction, and
    5. serious cardiac arrhythmias including sudden cardiac arrest.
    6. length of ICU and hospital stay for patients with and without uncontrolled tachycardia



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585311


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Stephan A Mayer, MD Columbia University
Study Director: J. Michael Schmidt, PhD Columbia University

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Responsible Party: Stephan A. Mayer, Professor of Neurology, Columbia University
ClinicalTrials.gov Identifier: NCT01585311     History of Changes
Other Study ID Numbers: AAAA5384
First Posted: April 25, 2012    Key Record Dates
Last Update Posted: April 25, 2012
Last Verified: April 2012

Keywords provided by Stephan A. Mayer, Columbia University:
Subarachnoid Hemorrhage (SAH)
tachycardia
Outcome

Additional relevant MeSH terms:
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Hemorrhage
Subarachnoid Hemorrhage
Intracranial Hemorrhages
Tachycardia
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases