Lactate in Cardiac Arrest

NCT02352350 | Withdrawn

• 1 other identifier: IRB201300816
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiac Arrest; Neurological Injury

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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; Other: Neurological Outcomes

Interventions

Blood Lactate Levels OTHER

Blood lactate levels will be performed on all participants.

Cardiac Arrest Patients

Neurological Outcomes OTHER

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

Also known as: Cerebral Performance Categories (CPC) Scale

Cardiac Arrest Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All adult patients (≥ 18 years of age)
• Non-traumatic primary cardiac arrest

You may not qualify if:

• Patients with advanced directives precluding resuscitation,
• Traumatic cardiac arrest, and
• Irreversible signs of death (rigor mortis).

Sponsors & Collaborators

• University of Florida: lead
• Alachua County Fire Rescue: collaborator

MeSH Terms

Conditions

Heart Arrest; Trauma, Nervous System

Interventions

cytidylyl-(3'-5')-cytidine; Weights and Measures

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Karl Huesgen, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: February 2, 2015
• Study Start: September 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: January 1, 2019
• Last Updated: October 24, 2017

Record last verified: 2017-10