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Lactate in Cardiac Arrest

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02352350
Recruitment Status : Withdrawn (Measurement devices unavailable at this time.)
First Posted : February 2, 2015
Last Update Posted : October 24, 2017
Sponsor:
Collaborator:
Alachua County Fire Rescue
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment
Cardiac Arrest Neurological Injury 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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Predictive Value of Prehospital Blood Lactate Measurement Following Out of Hospital Cardiac Arrest (OHCA) and Return of Spontaneous Circulation (ROSC).
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

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 Name: Cerebral Performance Categories (CPC) Scale




Primary Outcome Measures :
  1. Blood Lactate Levels correlated with survival [ Time Frame: Changes in hour 0, approximately hour 12, approximately day 14, and 6 months ]
  2. Blood Lactate Levels correlated with Neurological Outcomes [ Time Frame: Changes in week 2 and 6 months ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352350


Sponsors and Collaborators
University of Florida
Alachua County Fire Rescue
Investigators
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Principal Investigator: Karl Huesgen, MD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02352350    
Other Study ID Numbers: IRB201300816
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Pre-Hospital Cardiac Arrest
Blood Lactate Level
Neurological Injury
Additional relevant MeSH terms:
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Trauma, Nervous System
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Nervous System Diseases
Wounds and Injuries