Impact of Tachycardia on Outcome After Subarachnoid Hemorrhage (SAH)

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01585311

Enrollment

1540

Registered

2012-04-25

Start date

2008-03-31

Completion date

2015-08-31

Last updated

2019-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid Hemorrhage (SAH), Tachycardia

Keywords

Subarachnoid Hemorrhage (SAH), tachycardia, Outcome

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
modified Rankin Scale (mRS) score	Three months

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results