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Vitamins

Vitamin D

Cholecalciferol

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Calcium

Calcium, Dietary

Vitamin D3

Calciferol

Cholecalciferol/Vitamin D3 (540,000 IU orally or by feeding tube once)

Placebo

Michael Karsy, MD, PhD

Min S Park, MD

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.

Hypovitaminosis D in Neurocritical Patients

Randomized Clinical Trial of Hypovitaminosis D Treatment in the Neurocritical Care Unit

Two-sided t-test evaluated comparing length of stay in vitamin D3 vs. placebo treated patients utilizing patients after randomization, factoring excluded patients (e.g., as-treated) using a p\<0.05 as significant.

Two-sided t-test evaluated comparing length of stay within the ICU specifically in vitamin D3 vs. placebo treated patients utilizing patients after randomization (e.g., intent-to-treat) using a p\<0.05 as significant.

Two-sided t-test evaluated comparing length of stay within the ICU specifically in vitamin D3 vs. placebo treated patients utilizing patients after randomization but excluding patients who did not receive treatment (e.g., as-treated) using a p\<0.05 as significant.

The occurrence of patients who suffered mortality, adverse events or severe adverse events, related specifically to the study drug was monitored. Severe adverse events are defined using common terminology criteria for adverse events (CTCAE) grade 3 or higher specific to vitamin D from time of study drug administration to discharge.

University of Utah

M.D. Ph.D.

Catalog of CTCAE grade 3 or 4 adverse events directly related to study drug. Only adverse events or severe adverse events, related specifically to the study drug, were monitored. No serious events in any organ system were identified in this study and thus the listing of only the main heading for Serious Adverse Events and Other (Not Including Serious) Adverse Events reflects this, which is accurate and appropriate.

Patient demographics of patients receiving study drug

Patient demographics of patients receiving placebo

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Michael Karsy

Two-sided t-test evaluated comparing length of stay in vitamin D3 vs. placebo treated patients utilizing patients as randomized (e.g., intent-to-treat) using a p\<0.05 as significant. Adverse events were monitored until discharge.

Intent-to-treat Hospital Length-of-stay

As-treated Hospital Length of Stay

Intent-to-treat ICU Length of Stay

As-treated ICU Length of Stay

In-hospital Mortality

Adverse events were monitored until patient discharge from the hospital.

Number of Participants With Study Drug Related Adverse Events

Number of Participants With Sepsis

Number of Participants With Pneumonia

Number of Participants With Urinary Tract Infection

Number of Participants With Deep Vein Thrombosis

Placebo control (simple oral syrup)

Placebo: Oral syrup placebo

Cholecalciferol/Vitamin D3 (540,000 IU orally or by feeding tube once)

Cholecalciferol

Overall Study

Coagulants

Hemostatics

Marco Fabio Gemma, Dr

Carolina Iaquaniello, Dr

Marco Gemma, MD

The objective of this observational study is to examine the impact of augmented arterial pressure during the hemostatic phase of elective supratentorial neurosurgery. The primary inquiries it seeks to address are as follows:

1. Does an increase in systolic arterial pressure prompt a hemostatic maneuver by the neurosurgeon, and does the concomitant mean arterial pressure value influence the frequency of such interventions?
2. How often do postoperative intracranial hemorrhages occur, and how severe are they in relation to the achieved mean arterial pressure value?

Participants will be enrolled during the preoperative evaluation, where their arterial pressure values, medical histories, and medication statuses will be recorded. Throughout the induction and maintenance of anesthesia, we will monitor their blood pressure values and document any instances of hypotension or hypertension. During the hemostatic phase, we will elevate the arterial pressure using noradrenaline by up to 10 mmHg above the recorded pressure measured at the inpatient clinic. Subsequently, we will inquire whether the neurosurgeon had to employ any additional hemostatic maneuvers following the increase in arterial pressure. The arterial pressure values will be recorded at the end of the surgery, and the first postoperative CT scan will be examined to identify any cases of intracranial hemorrhage.

During surgery to remove intracranial tumors, a patient's blood pressure is kept moderately low to facilitate the procedure. Subsequently, a surgical phase of hemostasis is performed. At this stage, the standard clinical practice requires the anesthesiologist to raise blood pressure to challenge the surgical hemostasis. Although this practice may be considered ubiquitous, it is not currently described in neuroanesthesia texts, and no studies are available that report the effect of this maneuver, either in terms of the optimal level of pressure elevation or in terms of the greater efficacy of a target of systolic arterial pressure (SAP) rather than mean arterial pressure (MAP). The most frequently sought increase in everyday clinical practice is about 10 mmHg higher than the first SAP measured in the patient's operating room. Because of the different profiles of brain autoregulation (Smith, 2015) and individual cardiovascular profiles, anticipatory and context anxiety accompanying the time of surgery, in line with the literature, the present study prefers to select the blood pressure value measured on the ward at the time of admission as the reference (Ackland et al., 2019; Ard \& Kendale, 2016). The study aims first to observe the effects on the operative field of this increase.

* Primary objective: To verify how frequently the SAP-increasing maneuver prompts the Neurosurgeon to perform a hemostatic maneuver on the surgical field and to evaluate whether the concomitant MAP value reached affects this frequency.
* Secondary objective: To quantify the frequency and severity of any postoperative intracranial hemorrhage in relation to the achieved MAP value.

There are no pharmacological strategies to increase SAP and MAP selectively. However, it can be estimated that the increase mentioned above in SAP, achieved in our institute with an intravenous norepinephrine infusion, is not accompanied by a parallel increase in MAP in about 50 percent of cases (unpublished data).

Arterial Pressure and Surgical Hemostasis in Elective Neurosurgery.

The Effect of Arterial Pressure on Surgical Hemostasis During Elective Supratentorial Neurosurgery: a Prospective Observational Study.

We document the frequency with which the primary operators indicate the need for additional maneuvers once the target systolic arterial pressure (SAP) exceeds a 10 mmHg increase from the baseline relative to the achieved mean arterial pressure (MAP) value.

In relation to the MAP value achieved, we register the number of times the presence of a neurosurgical site hemorrhage calls for a novel surgical treatment or significant therapy adjustments.

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Glioma

Constriction, Pathologic

Carotid Stenosis

Carotid Artery Diseases

Arterial Occlusive Diseases

biological samples analysis

Xiaolin Chen, MD

Fa Lin, MD

Runting Li, MD

Yitong Jia, MD

Ke Wang, MD

Plastic particles are a ubiquitous pollutant in the living environment and food chain, so far, plenty of studies have reported the internal exposure of microplastics and nanoplastics in human tissues and enclosed body fluids.

Neurosurgery is the only department that can open the skull. In addition to blood and cerebrospinal fluid, there are brain tissue and tumors in the presence of lesions. Whether any of these microplastics and nanoplastics are present remains a mystery. This prospective observational study will harvest biological samples of neurosurgery patients.

The objective of this research is to be able to detect microplastics and nanoplastics on blood and operation samples of neurosurgery patients.

Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)

Presence of Microplastics and Nanoplastics in Neurosurgery Patients

Detection of microplastics in human brain tissue and the blood undergoing neurosurgery

Detection of nanoplastics in human brain tissue and the blood undergoing neurosurgery

Beijing Tiantan Hospital

Director

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hypovitaminosis D in Neurocritical Patients	NCT02881957	Craniocerebral ... Intracranial An... Brain Neoplasms Spinal Cord Inj... Seizures Meningitis Stroke Intracranial He... Critical Illnes... Vitamin d Defic...	Cholecalciferol Placebo	18 Years -	University of Utah
Arterial Pressure and Surgical Hemostasis in Elective Neurosurgery.	NCT05874050	Neurosurgery Intracranial He... Supratentorial ... Blood Pressure		18 Years -	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)	NCT05968053	Carotid Artery ... Glioma Intracranial An... Intracranial He... Brain Tumor	biological samp...	18 Years - 80 Years	Beijing Tiantan Hospital
Arterial Pressure and Surgical Hemostasis in Elective Neurosurgery.	NCT05874050	Neurosurgery Intracranial He... Supratentorial ... Blood Pressure		18 Years -	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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