Impact of Tachycardia on Outcome After Subarachnoid Hemorrhage (SAH)

Impact of Prolonged Tachycardia on Cardiovascular Morbidity and Outcome After Subarachnoid Hemorrhage (SAH)

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).

Study Overview

• Status: Terminated
• Conditions: Tachycardia; 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 Type: Observational
• Enrollment (Actual): 1540

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
modified Rankin Scale (mRS) score	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Major Adverse Cardiovascular Events (MACE)	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	3 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Jan Claassen, MD, Columbia University; Study Director: J. Michael Schmidt, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: April 24, 2012
• First Submitted That Met QC Criteria: April 24, 2012
• First Posted (Estimate): April 25, 2012

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 6, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Outcome; tachycardia; Subarachnoid Hemorrhage (SAH)
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Intracranial Hemorrhages; Hemorrhage; Tachycardia; Subarachnoid Hemorrhage
• Other Study ID Numbers: AAAA5384