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

NCT00593164 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-08-25

No results posted yet for this study

Summary

This study will involve the use of therapeutic hypothermia. This prospective cohort pilot study will evaluate the clinical performance of a new device, the ThermoSuit™ System, to achieve therapeutic hypothermia in comatose patients following resuscitation from cardiac arrest, and the impact of the vasodilator, magnesium sulfate, on cooling performance and hemodynamics in these patients. The study hypothesis is that magnesium sulfate will significantly increase the rate of cooling.

Conditions

  • Death, Sudden, Cardiac
  • Coma

Interventions

DEVICE

Cooling with ThermoSuit with Magnesium Sulfate Infusion

Cooling with LRS ThermoSuit within 15 minutes of intravenous Magnesium Sulfate infusion (30 mg/kg, added to 100 ml normal NaCl solution, given over 15 min).

DEVICE

Cooling with ThermoSuit with Normal Saline Infusion

Cooling with LRS ThermoSuit within 15 minutes of normal saline infusion (100 ml of normal NaCl solution, given over 15 min).

Sponsors & Collaborators

  • Medical University of Vienna

    collaborator OTHER

  • Life Recovery Systems

    lead OTHER

Principal Investigators

  • Michael Holzer, M.D. · Department of Emergency Medicine, Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2018-02-28
Completion
2018-04-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00593164 on ClinicalTrials.gov