Lactate in Cardiac Arrest

The Predictive Value of Prehospital Blood Lactate Measurement Following Out of Hospital Cardiac Arrest (OHCA) and Return of Spontaneous Circulation (ROSC).

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardiac Arrest; Neurological Injury
• Intervention / Treatment: Other: Blood Lactate Levels; Other: Neurological Outcomes

Detailed Description

This will be a prospective observational study of all primary cardiac arrest patients with prehospital (ROSC) in Alachua County, Florida. After Emergency Medical Services (EMS) activation and arrival at scene of a cardiac arrest, paramedics and Emergency Medical Technicians (EMTs) will provide standard Advanced Cardiac Life Support (ACLS) following 2010 guidelines. This may include chest compressions, early identification and shock of ventricular fibrillation and ventricular tachycardia, obtaining intravenous (IV) or intraosseous (IO) access, administration of IV or IO epinephrine, amiodarone, and pressors, oxygenation and ventilation, and other treatments as indicated for reversible causes of cardiac arrest. At time of IV or IO establishment a small blood sample will be obtained the blood will be measured for blood lactate. EMS personnel will be specifically trained to not to delay care or deviate from standard resuscitation protocols to obtain blood lactate sample. Current local paramedic protocols for cardiac arrest and general medical management include obtaining IV access and capillary blood draw and thus blood lactate measurement does not require any additional invasive procedures or medical risk. As medical director of Alachua County Fire Rescue (ACFR) as well as University of Florida faculty member, Dr. Christine Van Dillen oversees paramedic training, protocol development, and quality assurance in Alachua County, Florida. Dr Karl Huesgen is a faculty physician at the University as well, and works closely with ACFR in these regards. These investigators meet regularly with ACFR administration and provide mandatory paramedic and EMT education. Incorporation of lactate measurement into standard cardiac arrest protocols will be accomplished through the monthly administrative updates and monthly in-person training sessions. Adherence to the investigative protocol will be monitored through the standard quality assurance program in which all cardiac arrests are reviewed. Paramedics will have the option of using either capillary or venous blood for lactate measurement. This flexibility is important because cardiac arrests are often chaotic with substantial variability between site of cardiac arrests, timing of return of spontaneous circulation (e.g. if IV access obtained before cardiac rhythm restoration), patient anatomy (e.g. poor venous access), provider resources (e.g. presence of additional rescue personnel), and other factors. Ideally blood lactate measurement will occur at IV insertion, though it may be measured later with equally valid results during fingerstick glucose measurement. Of note, medical providers will be instructed to not perform any additional IV insertions or fingersticks in order to obtain lactate measurements. Patients will be transported as rapidly as possible to local hospitals.

• Study Type: Observational

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: Probability Sample

Study Population

All primary cardiac arrest patients in Alachua County with prehospital return of spontaneous circulation (ROSC) in Alachua County, FL.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac Arrest Patients; All adult patients with non traumatic cardiac arrest in Alachua County Florida will have blood lactate levels taken and neurological outcomes performed based on the Cerebral Performance Categories (CPC) Scale	Other: Blood Lactate Levels; Blood lactate levels will be performed on all participants.; Other: Neurological Outcomes; Neurological outcomes will be performed on all participants based on the Cerebral Performance Categories (CPC) Scale.; Other Names: Cerebral Performance Categories (CPC) Scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Lactate Levels correlated with survival		Changes in hour 0, approximately hour 12, approximately day 14, and 6 months
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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Alachua County Fire Rescue
• Investigators: Principal Investigator: Karl Huesgen, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: December 4, 2014
• First Submitted That Met QC Criteria: January 27, 2015
• First Posted (Estimate): February 2, 2015

Study Record Updates

• Last Update Posted (Actual): October 24, 2017
• Last Update Submitted That Met QC Criteria: October 20, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Neurological Injury; Pre-Hospital Cardiac Arrest; Blood Lactate Level
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Wounds and Injuries; Heart Arrest; Trauma, Nervous System
• Other Study ID Numbers: IRB201300816

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No