Intravascular cooling for rapid induction of moderate hypothermia in severely head-injured patients: results of a multicenter study (IntraCool)
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To evaluate the feasibility, safety and effectiveness of a new method of intravascular temperature management for inducing moderate hypothermia (MHT).
Design and settings
Prospective, international-multicenter clinical trial conducted in four university hospitals.
In a 2-year period 24 patients with severe head injury and refractory high ICP were treated with MHT (32.5°C) by intravascular methods.
Seventeen were males and seven females, with a median age of 25 years (range 15–60). The median Glasgow Coma Scale upon admission was 7 (range 3–13) and the median Injury Severity Score was 22 (range 13–43). A total of 75% of patients presented a diffuse lesion in the pre-enrollment computed tomography. Median time from injury until reaching refractory high ICP was 71.5 h after injury (minimum 14 h, maximum 251 h). Twelve patients (50%) reached this situation within the first 72 h after injury. MHT was attained in a median time of 3 h. Pre-enrollment median ICP was 23.8 mmHg and was reduced to 16.8 mmHg upon reaching target temperature. At 6 months after injury, nine patients had died (37.5%), six were severely disabled (25%), two moderately disabled (8.3%) and seven had a good recovery (29.2%). Of the nine patients who died, in four the cause was rebound ICP during rewarming, one death was attributed to accidental potassium overload, two to septic shock, one to cardiac arrest of unknown origin and the ninth to a pulmonary embolism.
Intravascular methods to induce MHT combined with precooling with cold saline at 4°C appear to be feasible and effective in reducing ICP in patients with high ICP refractory to first-line therapeutic measures.
KeywordsIntravascular temperature management Moderate hypothermia Pilot study Refractory high ICP Severe head injury Traumatic brain injury
We greatly appreciate the generous help in designing the protocol provided by Prof. Daniel I. Sessler, M.D., Chair of Department of Outcomes Research at the Cleveland Clinic, L&S Weakley professor and Director of the Outcomes Research Institute at the University of Louisville, Kentucky, USA. We thank Bessy Benejam, neuropsychologist who evaluated our patients’ 6-month outcome and collected the outcome data for all the participating centers. We also thank Sabrina Voss for correcting the manuscript. This study is supported in part by grants number PI030153 and PI051092 from Fondo de Investigaciones Sanitarias (FIS) awarded to Dr. J. Sahuquillo. Anna Vilalta and Mari-Angels Merino are funded by grants from the Institut de Recerca Vall d’Hebron.
Conflicts of interest
The Neurotraumatology Research Unit of the Vall d’Hebron University Hospital received a grant from the Alsius Corporation (Irvine, California, USA) to develop software used for data collection in this multicenter trial. The Alsius Corporation also donated all the disposables and catheters that were used in the study. The full responsibility for the scientific conduct of the study, data collection and statistical analysis was assumed by the coordinating center. Alsius Corporation neither participated in the design of the study, nor in the analysis of the results, nor in the writing of the manuscript. No restrictions were imposed by the sponsor on the scientific conduct and interpretation of the trial. The corresponding author owns the original data and made the decision to submit the study for publication. None of the participants in the clinical trial have received payment for consultancy and/or advisory work, honoraria for educational or other purposes, including travel or other expenses. None of the participants hold stocks or shares in Alsius Corporation. Dr. Daniel I. Sessler, who provided assistance in reviewing the IntraCool study protocol, is a consultant for Radiant Medical, Inc. Alsius Corporation did not participate in the design of the study, in the preparation of the manuscript or in data analysis. Alsius Corporation did not receive a copy of the manuscript for review. At the beginning of the study, Alsius Corporation was informed of the three patients who failed to undergo hypothermia within the expected time. The main reason for doing this was to have their feedback regarding potential causes of failure. They also received a graph similar to Fig. 1 for their internal use.
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