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Phase 1 N=16 Treatment

Reoxygenation After Cardiac Arrest II (REOX II Study)

Cardiac Arrest

Bottom Line

View on ClinicalTrials.gov: NCT02698826 ↗
Enrolled (actual)
16
Serious AEs
87.5%
Results posted
Mar 2022
Primary outcome: Primary: Plasma Isofurans (pg/mL)/Isoprostanes (pg/mL) Ratio

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Protocol for rapid FiO2 optimization (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
The Cooper Health System
Primary completion
Oct 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Plasma Isofurans (pg/mL)/Isoprostanes (pg/mL) Ratio		 — —
SECONDARY
Modified Rankin Scale (mRS) (Primary Neurological Outcome)		 6 —

Summary

The broad objective of this study is to test the association between hyperoxia exposure after resuscitation from cardiac arrest and outcome. After obtaining written informed consent subjects enrolled in REOX II will undergo a rapid faction of inspired oxygen (FiO2) optimization protocol to prevent exposure to hyperoxia. We will compare outcomes between subjects enrolled in REOX I (observational study only) and REOX II (intervention: rapid FiO2 optimization protocol). Our overarching hypothesis is that exposure to hyperoxia after return of spontaneous circulation (ROSC) is associated with increased oxidative stress and worsened neurological and cognitive outcomes.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Presumed etiology of arrest is trauma
  • Presumed etiology of arrest is hemorrhage
  • Presumed etiology of arrest is sepsis
  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02698826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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