Trial · Interventional

CompletedNot applicableRegistry data

GLP-1 Analogs for Neuroprotection After Cardiac Arrest

Short name GLIP1

NCTNCT02442791Other id2013-TTMPharma-001

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 120 participants (actual)
Sponsor: Jesper Kjaergaard · Other
Design: Randomized · Quadruple masking
Countries: 1 country
Denmark
Start: Jun 2014
Primary completion: Jun 2016
Completion: Jun 2016
First posted: 13 May 2015 (estimated)
Last update posted: 28 Sept 2017
Conditions: Cardiac Arrest · Coma

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2014201520162017

N/A
GLIP1
NCT02442791
Jun 2014 to Jun 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Byetta (Lilly, Exenatide)Drug
20% Human AlbuminOther

Arms2

Experimental
GLP-1
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.
Placebo comparator
Placebo
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.

Primary outcomes2

Outcomes the sponsor listed as primary.

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

Secondary outcomes(6)

Neurological prognostication
Time frame · Day 5
Registry description
Blinded neurological evaluation by neurologist on "VAS-scale"
Area under Neuron-specific Enolase curves (NSE)
Time frame · 48 hours
Registry description
Daily measurements of NSE values
All cause mortality
Time frame · 180 days
Registry description
Vital status by end of study by registry based follow-up
Cerebral status
Time frame · 30 days, 90 days and 180 days
Registry description
Telephone based assessment of Cerebral Performance Category and modified Rankin Scale.
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
Time frame · 48 hours
Registry description
Daily measurements of S100b

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2018

5 results

The Glucagon-Like Peptide-1 Analog Exenatide Increases Blood Glucose Clearance, Lactate Clearance, and Heart Rate in Comatose Patients After Out-of-Hospital Cardiac Arrest.

Wiberg et al. 2018Critical care medicinecited by 10

PMID 29189347DOI 10.1097/ccm.0000000000002814PUB-29189347

Full text at the publisher5 results

Publisher page See results (5)

Indexing hint: Randomized controlled trial · 2016

5 results

Neuroprotective Effects of the Glucagon-Like Peptide-1 Analog Exenatide After Out-of-Hospital Cardiac Arrest: A Randomized Controlled Trial.

Wiberg et al. 2016Circulationcited by 51

PMID 27838646DOI 10.1161/circulationaha.116.024088PUB-27838646

Full text at the publisher5 results

Publisher page See results (5)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedToftgaard Pedersen A, Kjaergaard J, Hassager C, Frydland M, Hartvig Thomsen J, Klein A, Schmidt H, Moller JE, Wiberg S. Association between inflammatory markers and survival in comatose, resuscitated out-of-hospital cardiac arrest patients. Scand Cardiovasc J. 2022 Dec;56(1):85-90. doi: 10.1080/14017431.2022.2074093. PMID 35546563
DerivedWiberg S, Hassager C, Thomsen JH, Frydland M, Hofsten DE, Engstrom T, Kober L, Schmidt H, Moller JE, Kjaergaard J. GLP-1 analogues for neuroprotection after out-of-hospital cardiac arrest: study protocol for a randomized controlled trial. Trials. 2016 Jun 30;17(1):304. doi: 10.1186/s13063-016-1421-2. PMID 27363489

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Out of hospital cardiac arrest (OHCA) of presumed cardiac cause * Sustained return of spontaneous circulation (ROSC) * Unconsciousness (GCS \<8 (Glasgow coma scale)) (patients not able to obey verbal commands) * Sustained ROSC (Sustained ROSC: Sustained ROSC is when chest compressions have been not required for 20 consecutive minutes and signs of circulation persist) Exclusion Criteria: * Conscious patients (obeying verbal commands) * Females of childbearing potential (unless a negative pregnancy test can rule out pregnancy within the inclusion window) * In-hospital cardiac arrest (IHCA) * OHCA of presumed non-cardiac cause, e.g. after trauma or dissection/rupture of major artery OR Cardiac arrest caused by initial hypoxia (i.e. drowning, suffocation, hanging). * Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, clopidogrel) does not exclude the patient). * Suspected or confirmed acute intracranial bleeding * Suspected or confirmed acute stroke * Unwitnessed asystole * Known limitations in therapy and Do Not Resuscitate-order * Known disease making 180 days survival unlikely * Known pre-arrest cerebral performance category 3 or 4 * \>4 hours (240 minutes) from ROSC to screening * Systolic blood pressure \<80 mm Hg in spite of fluid loading/vasopressor and/or inotropic medication/intra aortic balloon pump/axial flow device\* * Temperature on admission \<30°C. * Known allergy to GLP-1 analogs, including Exenatide * Known pancreatitis * Diabetic ketoacidosis, * Uncorrected blood glucose at admission \< 2.5 mmol/l. * If the systolic blood pressure (SBP) is recovering during the inclusion window (220 minutes) the patient can be included.

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