Bacterial Meningitis Clinical Trial
Official title:
Mild Induced Hypothermia to Treat Severe Community Acquired Meningitis in Adults Admitted to Intensive Care Unit
Bacterial meningitis is a severe infection of the envelope which surrounds the brain. It is
sometimes responsible for a cerebral oedema mattering with a loss of consciousness (coma).
The usual treatment of this affection is based on the antibiotic therapy, anti-inflammatory
drug and resuscitation measures in intensive care setting but the prognosis of comatose
patients remains poor.
Moderate hypothermia (body temperature is downed between 32 and 34°C°) made the proof of its
efficiency in certain cerebral pathologies (notably the cerebral distress after cardiac
arrest or oxygen lack in neonates) but was never evaluated in meningitis. In meningitis
animal studies and in severe traumatic brain injury, moderate hypothermia is able to
diminish cerebral oedema and brain inflammation.
Thus, the objective of this study is to compare two strategies: only usual care or usual
care completed by moderate hypothermia. The body temperature will be lowered between 32 and
34°C by means of a catheter placed in a big vein and connected to a machine in which
circulates a cold liquid, or by means of an external cooling (ice-cold blanket, ice packs
placed on the body). Whatever technique is chosen, the technique is perfectly mastered by
the teams which take charge of the patients. After 48 hours, the technique of hypothermia
will be suspended and body temperature will return passively and gradually to normal.
The investigators believe that moderate hypothermia will improve the prognosis of the most
severe patients.
Investigational procedure:
This study evaluates the impact of mild induced hypothermia (32-34°C) during 48 hours
followed by passive rewarming according to recommendations described in appendix. All
treatment will be according to local recommendations and guidelines of medical societies and
literature. Physicians are advised to use these recommendations; however, the best treatment
option for the individual patient should be used.
Mild Induced hypothermia:
Investigators are advised to use the cooling techniques as used in patients with cardiac
arrest. Thus, the choice of cooling method will be left to investigators. Hypothermia will
be induced by cold saline infusion as described in appendix 5 [6, 48]. Core temperature will
be monitored by oesophageal probe and maintained between 32°C and 34°C during 48 hours and
followed by strictly passive rewarming. During this phase of treatment, patients will
receive deep sedation associated with neuromuscular blockers. Centers participating to the
trial will have expertise in cooling methods.
Controls:
Controls will receive standard care and will be also be deeply sedated for 48 hours.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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