Reoxygenation After Cardiac Arrest II (REOX II Study)

NCT02698826 | Completed Phase 1 Results DMC

• 2 other identifiers: REOX IIR01HL112815
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Cardiac Arrest

Keywords

Cardiac Arrest, Hyperoxia, Ischemia-reperfusion Injury, Reactive Oxygen Species, Oxidative Stress, Neuropsychological Tests

Outcome Measures

Primary Outcomes (1)

• Plasma Isofurans (pg/mL)/Isoprostanes (pg/mL) Ratio

  Change in the isofurans/isoprostanes ratio between 0 and 6 hours post-ROSC

Secondary Outcomes (1)

• Modified Rankin Scale (mRS) (Primary Neurological Outcome)

  Upon hospital discharge, on average two weeks

Other Outcomes (1)

• Composite Neuropsychological Testing Score

  180 days

Study Arms (1)

Adult patients resuscitated from cardiac arrest

EXPERIMENTAL

Rapid FiO2 optimization protocol

Other: Protocol for rapid FiO2 optimization

Interventions

Protocol for rapid FiO2 optimization OTHER

We plan to test a protocol for FiO2 optimization for mechanically ventilated post-cardiac arrest subjects, with a therapeutic goal of partial pressure of arterial oxygen (PaO2) of 60-99 mmHg, based on the PaO2 range that was associated with the lowest risk of poor outcome in our previously published work. We also use PaO2 (measured by arterial blood gas \[ABG\] analysis) as the ultimate goal rather than arterial oxygen saturation (SaO2) measured by pulse oximetry because an SaO2 value \<100% on pulse oximetry monitoring does not always exclude supranormal PaO2. The protocol in this application begins with very rapid reduction of FiO2 as much as possible according to SaO2 values, and when FiO2 is maximally reduced by SaO2 an ABG is measured, followed by finer adjustment of FiO2 to achieve a PaO2 60-99 mmHg. The protocol not only prescribes each downward titration of FiO2 but it also includes detailed limbs for upward titration of FiO2 to account for potential "overshoot" in FiO2 reduction.

Adult patients resuscitated from cardiac arrest

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cooper Health System: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (5)

Indiana University/ Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Heart Arrest; Hyperoxia; Reperfusion Injury

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Brian Roberts, MD/ REOX Study Director
• Organization: Cooper University Health Care

roberts-brian-w@cooperhealth.edu

856-342-2352

Study Officials

• Stephen Trzeciak, MD, MPH

  The Cooper Health System

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 4, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 29, 2022
• Results First Posted: March 29, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)