GARDE : GC7 (N1-guanyl-1,7 Diaminoheptane) cARDiac arrEst

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice

About this trial

Cardiac arrest (CA) with return of spontaneous circulation is associated with high mortality, exceeding 90% in out-of-hospital settings and approaching 50% in in-hospital settings. Despite management of the underlying cause of CA, patients often die from post-anoxic brain injury or from ischemia-reperfusion injury occurring after reperfusion and reoxygenation, which increases oxidative stress and leads to multi-organ failure. To date, no effective therapeutic strategy has been established in humans to limit these ischemia-reperfusion injuries. GC7 (N1-guanyl-1,7 diaminoheptane) has demonstrated a strong protective potential against ischemia reperfusion injury in rodent and porcine models, including myocardial infarction, stroke, and renal transplantation. These protective effects are attributed to the pleiotropic action of GC7 which renders cells and tissues energetically less dependent on oxygen, and reduces oxidative stress which play a major role in ischemia reperfusion injury. Degree of blood acidification and immune dysregulation may also represent parameters that GC7 could potentially influence. Although no adverse effects have been reported in these experimental models, GC7 has not yet been studied in human. Our study therefore aims to demonstrate the protective effect of GC7 on blood cells in patients after CA by evaluating oxidative stress levels, blood acidification and inflammatory profile.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cardiac arrest as the primary reason for hospital admission

Admission < 48 hours

Age ≥ 18 years

Affiliated with a social security system

Disqualifiers

Limitation or withdrawal of life-sustaining therapies prior to study screening

Prior cardio-vascular ischemic event (> 24h) before cardiac arrest

Patient deprived of liberty

Trial design

Design model

Single group

Treatments tested in this trial

  • GC7 exposure

    Other intervention

    24-hour exposure of patient 's blood to GC7 molecule

  • No GC7 exposure

    Other intervention

    No exposure of blood to GC7 molecule

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: resuscitated cardiorespiratory arrestExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Blood oxidative stress levels

Time frame
at 24 hours after blood exposure to GC7

Secondary outcomes

1

Blood acidification

Time frame
24 hours after blood exposure to GC7
2

Blood inflammatory profile

Time frame
24 hours after blood exposure to GC7

Other outcomes

Sponsors and contacts

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