Impact of Tachycardia on Outcome After Subarachnoid Hemorrhage (SAH)

Sponsor

Columbia University (Other)

Overall Status

Terminated

CT.gov ID

NCT01585311

Collaborator

Baxter Healthcare Corporation (Industry)

1,540

Enrollment

Location

Duration (Months)

17.3

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Actual Enrollment :

1540 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 :

Mar 1, 2008

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Subarachnoid Hemorrhage patients SAH patients with hourly eMR values of Heart Rate

Outcome Measures

Primary Outcome Measures

modified Rankin Scale (mRS) score [Three months]

Secondary Outcome Measures

Prevalence of Major Adverse Cardiovascular Events (MACE) [3 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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