Cardiac Arrest Clinical Trial
Official title:
GLP-1 Analogs for Neuroprotection After Out-of-hospital Cardiac Arrest, a Randomized Clinical Trail
Experimental studies and previous clinical trials suggest neuroprotective effects of GLP-1 analogs in various degenerative neurological diseases, and in hypoxic brain injuries in experimental designs. This study is designed as a safety and feasibility study with patients randomized 1:1 to receive GLP-1 analogs immediately after hospital admission after out of hospital cardiac arrest.
In comatose patients resuscitated from out of hospital cardiac arrest, neurological injuries
remain the leading cause of death. The in-hospital mortality is reported at 30-50%, and the
total mortality, although improved substantially over the last decade, remain to be
significant, in most countries up to 90%. The brain of a patient resuscitated after cardiac
arrest (CA) may have suffered ischemia and when the spontaneous circulation is
re-established, the subsequent reperfusion may cause further damage. Brain ischemia and the
reperfusion injury lead to tissue degeneration and loss of neurological function, the extent
dependent on duration and density of the insult. Temperature control and mild induced
hypothermia (MIH) (33-36°C) mitigate this damage in the experimental setting and clinical
trials have shown promising results in improving neurological function and survival. Recent
large scale clinical trials however have investigated milder degree of hypothermia in this
setting, which suggest a role for active neuroprotection outside of temperature management.
Also recently, increased attention to the possible role of Glucagon-Like Peptide-1 (GLP-1) in
neuroprotection has been raised, both in the context of ameliorating degenerative disease and
in reducing inflammation on ischemic cerebral stroke.
Several experimental studies have shown that GLP-1 analogs has a beneficial effect in the
treatment of various degenerative neurological diseases such as Alzheimer's disease and
Parkinson's disease. GLP-1 analogs have been shown to reduce brain infarct size in mice after
focal brain ischemia as well as to reduce heart infarct size in swine in a model of
myocardial infarction.
Recent clinical testing in humans have demonstrated a benefit of GLP-1 infusion on myocardial
infarct size and a larger salvage index in patients with myocardial infarction. The GLP-1
analogs were infused in acutely ill patients in many ways similar to cardiac arrest patients
with no increased risk of adverse events.
This study is a double blinded randomized study seeking to evaluate the potential
neuroprotective effects of GLP-1 analogs infused in comatose patients after out of hospital
cardiac arrest.
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