Trial of Different Hypothermia Temperatures in Patients Recovered From Out-of-hospital Cardiac Arrest
Summary
Mild therapeutic hypothermia in the temperature range of 32º - 34ºC. improves survival in patients recovered from a ventricular fibrillation cardiac arrest. The same therapy is suggested with less evidence for asystole as first rhythm after cardiac arrest. The purpose of this study is to determine whether different temperature targets (32º vs 34º) may have different efficacy in the treatment of post-cardiac arrest patients. If successful, this pilot study will eventually form the basis for a larger, multicentric randomized clinical trial.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Conditions
Hypothermia, Induced
Intervention
Hypothermia to 32 degrees, Hypothermia to 34 degrees
Location
Intensive Cardiac Care Unit. Hospital Universitario la Paz
Madrid
Spain
28046
Status
Recruiting
Source
Hospital Universitario La Paz
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01155622
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Hypothermia, Induced
Abnormally low BODY TEMPERATURE that is intentionally induced in warm-blooded animals by artificial means. In humans, mild or moderate hypothermia has been used to reduce tissue damages, particularly after cardiac or spinal cord injuries and during subsequent surgeries.
Circulatory Arrest, Deep Hypothermia Induced
A technique to arrest the flow of blood by lowering BODY TEMPERATURE to about 20 degrees Centigrade, usually achieved by infusing chilled perfusate. The technique provides a bloodless surgical field for complex surgeries.
Rewarming
Application of heat to correct hypothermia, accidental or induced.
Systemic Inflammatory Response Syndrome
A systemic inflammatory response to a variety of clinical insults, characterized by two or more of the following conditions: (1) fever >38 degrees C or HYPOTHERMIA <36 degrees C; (2) TACHYCARDIA >90 beat/minute; (3) tachypnea >24 breaths/minute; (4) LEUKOCYTOSIS >12,000 cells/cubic mm or 10% immature forms. While usually related to infection, SIRS can also be associated with noninfectious insults such as TRAUMA; BURNS; or PANCREATITIS. If infection is involved, a patient with SIRS is said to have SEPSIS.
Hypothermia
Lower than normal body temperature, especially in warm-blooded animals; in man usually accidental or unintentional.
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PubMed Articles
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Survey of the use of therapeutic hypothermia post cardiac arrest.
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Environmental cooling of the newborn pig brain during whole body cooling.
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