drugset / Trial / NCT01573117

A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. RhinoChill (iCOOL 1)

NCT01573117

Phase 2 Completed 20 enrolled University Hospital Heidelberg
RandomizedParallel-groupOpen-labelTreatment

Summary

Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain swelling associated cerebrovascular disease. The narrow-time-frame is a major issue ("time is brain"). To provide immediate cooling without delay, easy to use, mobile and effective methods are needed. Cold infusions (4 °C) are an accepted standard worldwide. The RhinoChill (BeneChill, USA) is a new device. A comparison of these two induction methods has never been done before. Neither was the effect of cold infusions on brain-temperature measured. For the first time iCOOL 1 compares feasibility, safety and efficacy of the two methods.

Timeline

Start
2010-09
Primary completion
2011-11
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ringer's solution Unknown 2000 ml
Comparator sodium chloride Unknown 2000 ml