Recruiting

Observational Study

Sponsor:

MaineHealth

Code:

NCT02664831

Conditions

Cardiac Arrest

Inflammation

Obesity

Hypoxic Ischemic Encephalopathy (HIE)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

This is a prospective, observational study to investigate molecular mechanisms mediating the systemic inflammatory process, and changes to metabolism, and their impact on brain injury, survival, and functional outcomes after cardiac arrest. Investigators have shown that cardiac arrest induces changes in the numbers and properties of circulating immune cells, shifting the balance towards a pro-inflammatory phenotype and there is increased interest in the inflammatory pathways and the signaling mechanisms through which they are modulated. Participants will undergo blood sampling during 7 days following cardiac arrest, and analyses performed. Patient characteristics, clinical circumstances, and outcomes will be recorded and their associations with these inflammatory pathways characterized.

Conditions

Cardiac Arrest

Inflammation

Obesity

Hypoxic Ischemic Encephalopathy (HIE)

Study ID

NCT02664831

Start date

Jan, 2016

Status verified date

Jul, 2025

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Aged 18 years or older
  • Admitted to the intensive care unit after cardiac arrest episode
  • Unresponsive after resuscitation

Exclusion Criteria:

  • Moribund / actively dying at the time of evaluation
  • Informed consent cannot be obtained within 24 hours of resuscitation
  • Hemoglobin less than 7.0 g/dL, active high-volume bleeding, or requiring a transfusion

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Correlations between inflammatory markers and clinical outcomes [ Time Frame: 14 days ]
  • Correlations between inflammatory markers and biomarkers of neurological and cardiac injury [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Locations

Maine Medical Center

Recruiting

Portland, Maine, United States, 04102

Contacts

Principal Investigator:

David B Seder, MD

More Information

Sponsor

MaineHealth

Last update posted

Jul 18, 2025

Last verified

Jul, 2025

Keywords

  • cardiac arrest
  • inflammation
  • immune
  • neuregulin
  • lymphocyte
  • neutrophil
  • brown adipose
  • HIE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MaineHealth on 2025-07-18.