Impact of Tachycardia on Outcome After Subarachnoid Hemorrhage (SAH)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Stephan A. Mayer, Columbia University
ClinicalTrials.gov Identifier:
NCT01585311
First received: April 24, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  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)

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • modified Rankin Scale (mRS) score [ Time Frame: Three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major Adverse Cardiovascular events (MACE) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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


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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01585311

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Baxter Healthcare Corporation
Investigators
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