Recruitment

Recruitment Status
Completed
Estimated Enrollment
133

Inclusion Criterias

Clinician intent to treat with therapeutic hypothermia (or absence of clinician intent to withhold therapeutic hypothermia)
Endotracheal intubation
Return of spontaneous circulation
...
Clinician intent to treat with therapeutic hypothermia (or absence of clinician intent to withhold therapeutic hypothermia)
Endotracheal intubation
Return of spontaneous circulation
Not following commands immediately after ROSC
Age >17 years
Cardiac arrest

Exclusion Criterias

Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate, e.g. end stage chronic illness with no reasonable expectation of survival to hospital discharge
Presumed etiology of arrest is hemorrhage
Permanent resident of nursing home or other long-term care facility
...
Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate, e.g. end stage chronic illness with no reasonable expectation of survival to hospital discharge
Presumed etiology of arrest is hemorrhage
Permanent resident of nursing home or other long-term care facility
Presumed etiology of arrest is trauma
Presumed etiology of arrest is sepsis

Summary

Conditions
Cardiac Arrest
Type
Observational
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Specific Aim 1: Test if the degree and duration of hyperoxia following ROSC from cardiac arrest is associated with the degree of in vivo oxidative stress during the post-resuscitation phase of therapy. Approach: We will conduct a multicenter prospective observational study of adult patients resuscit...

Specific Aim 1: Test if the degree and duration of hyperoxia following ROSC from cardiac arrest is associated with the degree of in vivo oxidative stress during the post-resuscitation phase of therapy. Approach: We will conduct a multicenter prospective observational study of adult patients resuscitated from cardiac arrest. We will record data pertaining to oxygenation parameters and other factors and measure biomarkers of oxidative stress (isoprostanes and isofurans) in the plasma at 0 and 6 hours after ROSC using gas chromatography negative ion chemical ionization mass spectrometry. We will determine the exposure to post-ROSC hyperoxia by calculating the time-weighted average PaO2 and SaO2 for the post-resuscitation phase of therapy, and will test the association with plasma isoprostane and isofuran levels. Specific Aim 2: Test if the degree and duration of hyperoxia following ROSC from cardiac arrest is associated with the degree of neurological disability at hospital discharge. Approach: In the study described above, we will determine the Modified Rankin Scale at hospital discharge. We will perform multivariable analyses adjusted for numerous covariates known to be associated with outcome in post-cardiac arrest patients to determine if post-ROSC hyperoxia exposure is independently associated with neurological disability. Specific Aim 3: Test if the degree and duration of hyperoxia following ROSC from cardiac arrest is associated with neuropsychological outcomes among survivors at 180 days. Approach: In the study described above, we will assess neuropsychological outcome among survivors at 180 days. Neuropsychological testing will use validated instruments across five cognitive domains (attention, Wechsler Adult Intelligence Scale-IV-digit span; (2) reasoning, Wechsler Adult Intelligence Scale-IV-similarities; (3) immediate and delayed memory, Wechsler Memory Scale-III-logical memory I and II; (4) verbal fluency, Controlled Oral Word Association Test; and (5) executive functioning, Hayling Sentence Completion Test). We will perform multivariable analyses to determine if post-ROSC hyperoxia exposure is independently associated with neuropsychological deficits.

Inclusion Criterias

Clinician intent to treat with therapeutic hypothermia (or absence of clinician intent to withhold therapeutic hypothermia)
Endotracheal intubation
Return of spontaneous circulation
...
Clinician intent to treat with therapeutic hypothermia (or absence of clinician intent to withhold therapeutic hypothermia)
Endotracheal intubation
Return of spontaneous circulation
Not following commands immediately after ROSC
Age >17 years
Cardiac arrest

Exclusion Criterias

Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate, e.g. end stage chronic illness with no reasonable expectation of survival to hospital discharge
Presumed etiology of arrest is hemorrhage
Permanent resident of nursing home or other long-term care facility
...
Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate, e.g. end stage chronic illness with no reasonable expectation of survival to hospital discharge
Presumed etiology of arrest is hemorrhage
Permanent resident of nursing home or other long-term care facility
Presumed etiology of arrest is trauma
Presumed etiology of arrest is sepsis

Locations

Boston, Massachusetts, 02215
Camden, New Jersey, 08103
Philadelphia, Pennsylvania, 19104
Indianapolis, Indiana, 46202
Jackson, Mississippi, 39216
...
Boston, Massachusetts, 02215
Camden, New Jersey, 08103
Philadelphia, Pennsylvania, 19104
Indianapolis, Indiana, 46202
Jackson, Mississippi, 39216

Tracking Information

NCT #
NCT01881243
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Director: Stephen Trzeciak, MD, MPH The Cooper Health System