Impact of Tachycardia on Outcome After Subarachnoid Hemorrhage (SAH)

Terminated

• Conditions: Subarachnoid Hemorrhage (SAH); Tachycardia

• Registration Number: NCT01585311
• Lead Sponsor: 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).

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2012-04-24
• Study First Submitted QC: 2012-04-24
• Study First Posted: 2012-04-25
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-06
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1540

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

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Exclusion Criteria

• Age < 18yrs
• traumatic SAH
• SAH due to a rupture of an arteriovenous malformation, neoplasm vasculitis or other secondary causes

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
modified Rankin Scale (mRS) score	Three months

Secondary Outcome Measures

Name	Time	Method
Prevalence of Major Adverse Cardiovascular Events (MACE)	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

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States