hypovitaminosis d in neurocritical patients

Conditions: Craniocerebral Trauma; Intracranial Aneurysm; Brain Neoplasms; Spinal Cord Injuries; Seizures; Meningitis; Stroke; Intracranial Hemorrhages; Critical Illness; Vitamin d Deficiency

Summary: vitamin d has been shown to impact prognosis in a variety of retrospective and randomized clinical trials within an intensive care unit (icu) environment. despite these findings, there have been no studies examining the impact of hypovitaminosis d in specialized neurocritical care units (nccu). given the often significant differences in the management of patients in nccu and more generalized intensive care units there is a need for further inquiries into the impact of low vitamin d levels in this specific environment. this study proposes a randomized, double-blinded, placebo-controlled, single center evaluation of vitamin d supplementation in the emergent nccu patient population. the primary outcome will involve length-of-stay for emergent neurocritical care patients. various secondary outcomes, including in-hospital mortality, icu length-of-stay, glasgow outcome score on discharge, complications and quality-of-life metrics. patients will be followed for 6 months post-discharge.

vitamin d has been shown as an important marker of prognosis in a variety of clinical settings, including overall mortality, acute respiratory distress syndrome (ards), infection/sepsis, asthma, cardiovascular disease, diabetes, and pediatric/medical/surgical intensive care unit outcomes. vitamin d not only plays a role in bone maintenance, but also a variety of extra-axial functions including immune-dysregulation and systemic inflammation. in addition, a number of randomized clinical trials support the supplementation of vitamin d as improving outcome in critical care patients. while the evaluation of vitamin d levels remains a standard-of-care at our institution, the widespread use of vitamin d monitoring and impact on neurocritical care patients remains limited. the investigators' recent prospective observational study of vitamin d levels in neurocritical patients showed that deficiency (\<20ng/dl) was highly associated with prolonged hospital stay and increased in-hospital mortality for emergent patients. moreover, a number of limitations arise from this study due to its observational nature. this study proposes a randomized, double-blinded, placebo-controlled, single center evaluation of vitamin d supplementation in the neurocritical care patient population. patients admitted to the neurocritical care unit for emergent cases and with vitamin d deficiency (\<20ng/dl) will undergo vitamin d serum draw on admission and be randomized to receive cholecalciferol/vitamin d3 supplementation (540,000 iu once orally) or placebo. the primary outcome measured will be hospital length-of-stay. secondary outcomes will include length of icu course, complications, medication adverse events, discharge glasgow outcome score, in-hospital and 30-day mortality, as well as quality-of-life. power analysis estimates 198 patients will be needed for each subgroup to determine a 2 day difference in length-of-stay, and the study plans to recruit 218 patients per treatment arm to account for dropout, which will take approximately 6-9 months to recruit. interim analysis and safety monitoring will be performed. the investigators hypothesize that vitamin d supplementation may make a significant impact on reducing morbidity and mortality in the neurocritical care population. the possibility of reducing hospital length of stay and mortality from a simple, safe, and cost-effective intervention such as vitamin d supplementation may be a useful adjuvant treatment in the neurocritical care population.

Eligibility criteria:
inclusion criteria: * patients \>18 years of age * patients admitted to the neurosurgery or neurology services * patients admitted to a critical care unit * informed consent * expected to stay in the icu for 48 hours or more * vitamin d deficiency (\<20ng/ml) exclusion criteria: * patients where a vitamin d level was not drawn within 48 hours of admission * patients not randomized within 48 hours of admission * readmitted patients to the critical care unit * lack of informed consent * prior supplementation with vitamin d * severely impaired gastrointestinal function * other trial participation * pregnant or lactating women * hypercalcemia (total calcium of \>10.6 mg/dl or ionized serum calcium of \>5.4 mg/dl * tuberculosis history or clinical exam * sarcoidosis history or clinical exam * nephrolithiasis within the prior year * patients not deemed suitable for study participation (ie, psychiatric disease, living remotely from the clinic, or prisoner status) * pregnant or nursing women

Keywords: critical illness craniocerebral trauma intracranial aneurysm spinal cord injuries seizures meningitis stroke vitamin d deficiency cholecalciferol intracranial hemorrhages