An interventional study of Byetta (Lilly, Exenatide) and 20% Human Albumin in Cardiac Arrest and Coma, sponsored by Jesper Kjaergaard. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-28.
Sponsored by Jesper Kjaergaard · Not applicable, Interventional, and Treatment
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.
965 studies on the registry are indexed under Heart Arrest; 225 are open to participants now.
This study's enrollment of 120 is above the median of 100 across 556 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →Jesper Kjaergaard is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Uncorrected blood glucose at admission \< 2.5 mmol/l.
Half of the participants will receive the study drug, that will be given as follows: 250 mL isotonic sodium chloride added 1.5 mL of 20% Human Albumin added 25 microg Byetta (Lilly, Exenatide). The study drug infusion is initiated as soon as possible at rate of 72ml/hour (0.12 μg/min) for 15 min (set volume at 18 ml), followed by 26ml/hour (0.043 μg/min) to be continued for 6 hours (set volume at 156 ml). This concludes the pharmacological intervention.
Drug: Byetta (Lilly, Exenatide) · Other: 20% Human Albumin
Half of the participants will receive placebo, that will be given as follows: 250 mL isotonic sodium chloride added 1.5 mL of 20% Human Albumin. The placebo infusion is administered exactly the same way as the study drug infusion.
Other: 20% Human Albumin
See description of Arms
Also known as: Byetta
See description of Arms
Feasibility: Over 90% initiation of study drug infusion
Time frame: 4 hours from return of spontaneous circulation
Efficacy assessed by Area under the Neuron-specific Enolase curve
Time frame: 72 hours from admission
Neurological prognostication
Blinded neurological evaluation by neurologist on "VAS-scale"
Time frame: Day 5
Area under Neuron-specific Enolase curves (NSE)
Daily measurements of NSE values
Time frame: 48 hours
All cause mortality
Vital status by end of study by registry based follow-up
Time frame: 180 days
Cerebral status
Telephone based assessment of Cerebral Performance Category and modified Rankin Scale.
Time frame: 30 days, 90 days and 180 days
Safety: Cumulated incidence of serious adverse events related to study drug: death, need for mechanical hemodynamic support, hypoglycaemia < 3.0 mmol/l, pancreatitis (S-amylase > 3 UNL), need for renal replacement therapy in the first 3 days.
Time frame: 180 days
Area under S100b curve
Daily measurements of S100b
Time frame: 48 hours
Left Ventricular Ejection Fraction (LVEF)
LVEF on last in-hospital echocardiogram.
Time frame: Day 5 or later
EEG findings
Presence of EEG findings associated with poor prognosis.
Time frame: Day 3 to 5
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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