Impact of Tachycardia on Outcome After Subarachnoid Hemorrhage (SAH)

Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01585311
• Other study ID #: AAAA5384
• Status: Terminated
• Start date: March 2008
• Est. completion date: August 2015

Study information

• Verified date: September 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1540
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage (SAH)
• Tachycardia

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Scale (mRS) score		Three months
Secondary	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