Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients with Intravenous Infusion of Magnesium Sulfate

Conditions: Post resusucitation disease after resuscitation from cardiac arrest
MedDRA version: 9.1Level: LLTClassification code 10007515Term: Cardiac arrest
MedDRA version: 9.1Level: LLTClassification code 10029286Term: Neurologic disorder NOS
MedDRA version: 9.1Level: LLTClassification code 10059485Term: Therapeutic hypothermia

Registration Number: EUCTR2007-005178-30-AT

Lead Sponsor: ife Recovery Systems

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Cardiac arrest prior to or during hospital admission, with restoration/return of spontaneous circulation (ROSC).
2.Estimated or known age > 18 years.
3.Intubation, ventilation and placement of esophageal temperature probe.
4.Persistent neurologic dysfunction i.e. comatose upon enrollment [GCS = 8].
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Height greater than 188 cm.
2.Elbow-to-elbow width greater than 60 cm (as measured above the supine patient).
3.Core temperature less than 35°C after ROSC (as measured in the esophagus).
4.Comatose state before the cardiac arrest due to the administration of drugs that depress the central nervous system.
5.Known pregnancy.
6.Known terminal illness that preceded the arrest.
7.Known enrollment in another study of a device, drug, or biologic.
8.Major trauma or other co-morbidity requiring urgent surgery.
9.> 4 hours since return of spontaneous circulation.
10.Severe coagulopathy (with active bleeding).
11.Hemodynamic instability despite vasopressors (SBP < 90 mmHg or MAP < 60 mmHg for > 30 minutes after ROSC and before enrollment).
12.Bradycardia (HR<60/min)
13.Allergy against MgSo4
14.AV-block
15.Myasthenia gravis
16.Known terminal renal insufficiency (creatinine-clearence < 20ml/min)
17.Severe myocardial dysfunction (EF<25%)
18.Chronic digitalis therapy