Cardiac Arrest Clinical Trial
Official title:
The Predictive Value of Prehospital Blood Lactate Measurement Following Out of Hospital Cardiac Arrest (OHCA) and Return of Spontaneous Circulation (ROSC).
Verified date | October 2017 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Blood lactate levels will be measured using a simple handheld device at time of return of spontaneous circulation (ROSC) following out of hospital cardiac arrest (OHCA). Patient outcomes tracked will include rate of survival to hospital discharge, rate of 6 month survival, and neurological status. The hypothesis for this pre-hospital study is to confirm the previous in-hospital findings that very high blood lactate after ROSC is associated with very high mortality and severe neurological impairment.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2019 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All adult patients (= 18 years of age) - Non-traumatic primary cardiac arrest Exclusion Criteria: - Patients with advanced directives precluding resuscitation, - Traumatic cardiac arrest, and - Irreversible signs of death (rigor mortis). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Florida | Alachua County Fire Rescue |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood Lactate Levels correlated with survival | Changes in hour 0, approximately hour 12, approximately day 14, and 6 months | ||
Primary | Blood Lactate Levels correlated with Neurological Outcomes | Overall Neurologic function will be assessed using available clinical information and Cerebral Performance Categories, a composite measure including available neurologic and clinical assessments CPC 1. Good cerebral performance: conscious, alert, able to work, might have mild neurologic or psychological deficit. CPC 2. Moderate cerebral disability: conscious, sufficient cerebral function for independent activities of daily life. Able to work in sheltered environment. CPC 3. Severe cerebral disability: conscious, dependent on others for daily support because of impaired brain function. Ranges from ambulatory state to severe dementia or paralysis. CPC 4. Coma or vegetative state: any degree of coma without the presence of all brain death criteria. Unawareness, even if appears awake (vegetative state) without interaction with environment; may have spontaneous eye opening and sleep/awake cycles. Cerebral unresponsiveness. CPC 5. Brain death: apnea, areflexia, EEG silence, etc. |
Changes in week 2 and 6 months |
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