Cardiac ArrestNCT02352350
Lactate in Cardiac Arrest
An observational study of Cardiac Arrest and Neurological Injury, run by University of Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Neurological Injury
- What is being tested?
- Blood Lactate Levels and Neurological Outcomes
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All primary cardiac arrest patients in Alachua County with prehospital return of spontaneous circulation (ROSC) in Alachua County, FL.
Who may be able to join
- All adult patients (≥ 18 years of age)
- Non-traumatic primary cardiac arrest
Who cannot join
- Patients with advanced directives precluding resuscitation,
- Traumatic cardiac arrest, and
- Irreversible signs of death (rigor mortis).
About this study
Official title: 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.
Read the 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
- Being tested
- Blood Lactate Levels, Neurological Outcomes
- Keywords
- Pre-Hospital Cardiac Arrest, Blood Lactate Level, Neurological Injury
- Medical subject headings
- Heart Arrest, Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Lactate LevelsOther
Blood lactate levels will be performed on all participants.
Neurological OutcomesOther
Also called Cerebral Performance Categories (CPC) Scale
Neurological outcomes will be performed on all participants based on the Cerebral Performance Categories (CPC) Scale.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Blood Lactate Levels; Other: Neurological Outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Lactate Levels correlated with survival
Measured: 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.
Measured: Changes in week 2 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startSep 2017 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionJan 2019 (estimated)
Why it stopped: Measurement devices unavailable at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Alachua County Fire Rescue
- Responsible party
- Sponsor
- Investigators
- Karl Huesgen, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352350
- Sponsor's protocol ID
- IRB201300816
- Status last verified
- Oct 2017
- First submitted
- 4 Dec 2014
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Prehospital Blood Lactate Measurement Following Out of Hospital Cardiac Arrest (OHCA) and Return of Spontaneous Circulation (ROSC).
- ClinicalTrials.gov ID
- NCT02352350
- Acronym / sponsor ID
- IRB201300816
- Conditions
- Cardiac Arrest, Neurological Injury
- Keywords
- Pre-Hospital Cardiac Arrest, Blood Lactate Level, Neurological Injury
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Measurement devices unavailable at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Alachua County Fire Rescue
- Study start
- Sep 2017 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Arrest Patients | – | Other: Blood Lactate Levels, Other: Neurological OutcomesAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All primary cardiac arrest patients in Alachua County with prehospital return of spontaneous circulation (ROSC) in Alachua County, FL.
Key inclusion criteria (2 listed)
- All adult patients (≥ 18 years of age)
- Non-traumatic primary cardiac arrest
Key exclusion criteria (3 listed)
- Patients with advanced directives precluding resuscitation,
- Traumatic cardiac arrest, and
- Irreversible signs of death (rigor mortis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Lactate LevelsBlood lactate levels will be performed on all participants. | Other | Cardiac Arrest Patients |
| Neurological OutcomesAlso: Cerebral Performance Categories (CPC) ScaleNeurological outcomes will be performed on all participants based on the Cerebral Performance Categories (CPC) Scale. | Other | Cardiac Arrest Patients |
Primary outcome
Blood Lactate Levels correlated with survival
Time frame: Changes in hour 0, approximately hour 12, approximately day 14, and 6 months
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Huesgen, MD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Neurological Injury, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Lactate Levels correlated with survival (time frame: Changes in hour 0, approximately hour 12, approximately day 14, and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.