Lactate in Cardiac Arrest

NCT ID: NCT02352350

Last Updated: 2017-10-24

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-30
• Study Completion Date: 2019-01-31

Brief Summary

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.

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.

Conditions

Cardiac Arrest; Neurological Injury

Keywords

Pre-Hospital Cardiac Arrest; Blood Lactate Level; Neurological Injury

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Blood Lactate Levels

Intervention Type: OTHER

Blood lactate levels will be performed on all participants.

Neurological Outcomes

Intervention Type: OTHER

Neurological outcomes will be performed on all participants based on the Cerebral Performance Categories (CPC) Scale.

Interventions

Blood Lactate Levels

Blood lactate levels will be performed on all participants.

Intervention Type: OTHER

Neurological Outcomes

Neurological outcomes will be performed on all participants based on the Cerebral Performance Categories (CPC) Scale.

Intervention Type: OTHER

Other Intervention Names

Cerebral Performance Categories (CPC) Scale

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alachua County Fire Rescue

UNKNOWN

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karl Huesgen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Countries

United States

Other Identifiers

IRB201300816

Identifier Type: -

Identifier Source: org_study_id