Nervous System Diseases

Heart and Blood Diseases

All Conditions

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Neoplasms

Nutritional and Metabolic Diseases

Musculoskeletal Diseases

Rare Diseases

Stroke

Intracranial Hemorrhages

Hemorrhage

Aneurysm

Critical Illness

Spinal Cord Injuries

Seizures

Brain Neoplasms

Intracranial Aneurysm

Meningitis

Vitamin D Deficiency

Craniocerebral Trauma

Rickets

Avitaminosis

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Vascular Diseases

Spinal Cord Diseases

Trauma, Nervous System

Neurologic Manifestations

Disease Attributes

Deficiency Diseases

Malnutrition

Nutrition Disorders

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Nervous System Neoplasms

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Calcium Metabolism Disorders

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Vitamins

Vitamin D

Cholecalciferol

Trace Elements

Hormones

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

Moyamoya Disease

Carotid Artery Diseases

Cerebral Arterial Diseases

Arterial Occlusive Diseases

Group C means Control group which use Seldinger technique for subclavian catheterization. The aimed vessel(subclavian vein) is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and the needle is removed. After that catheter is passed over the guidewire into the vessel.

Group MS means experimental group which use modified Seldinger technique for subclavian catheterization. The aimed vessel is punctured with the needle that is covered with guiding sheath. After vessel is punctured, guiding sheath is instatntly slid over the needle into the vessel. The needle is removed, guidewire is advanced through the sheath, central catheter is placed into the vessel.

The aimed vessel(subclavian vein) is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and the needle is removed.

After that catheter is passed over the guidewire into the vessel.

Seldinger technique

The aimed vessel is punctured with the needle that is covered with guiding sheath. After vessel is punctured, guiding sheath is instantly slid over the needle into the vessel. The needle is removed, guidewire is advanced through the sheath, central catheter is placed into the vessel.

Modified Seldinger technique

Hee Pyung Park, MD PhD

Eugene Kim, MD

Seldinger technique is a minimally invasive technique in which the practitioner accesses the target vessel with a small bore needle, then dilates to the size required for the catheter. Contrarily, modified Seldinger technique(guiding sheath-over-the-needle technique) use needle that is covered with guiding sheath.

Both technique is widely used in central venous catheterization, however, few researches have been investigated to compare success rate or complications of both methods.

The major complications of central venous catheterization through subclavian vein, are unintended arterial puncture, pneumothorax, hemothorax, malposition of catheter etc,. We assume that using modified Seldinger technique (MST), guiding sheath is easily slid over the needle, providing stable route into the vessel lumen relatively.

We aimed to compare the Seldinger technique and modified Seldinger technique(MST) on success rate and complications during subclavian central venous catheterization in this prospective, randomized , controlled trials.

Subclavian Vein catheterization_Seldinger Vs Modified Seldinger

Comparison of Two Needle Insertion Techniques on Success Rate and Complications During Subclavian Venous Catheterization: Seldinger vs. Modified Seldinger Technique

Compare main complication rates of subclavian catheterization including pnumothorax, hemothorax, arterial puncture, malposition of cathter.

Check the number of attempts of needling, guidewire advance, and catheterization in both groups.

Check the total insertion time from skin puncture to confirm the successful catheterization via venous aspiration though catheter lumen.

Seoul National University Hospital

Professor

Skin and Connective Tissue Diseases

Ganglion Cysts

Synovial Cyst

Cysts

Mucinoses

Connective Tissue Diseases

Central Nervous System Depressants

Anesthetics

Ropivacaine

Anesthetics, Local

Experimental patients will receive a stellate ganglion block with 0.25% ropivacaine 6-8mL on the right side at the level of the sixth cervical vertebrae (C6) before surgery.Then the catheter will be attached to a single use patient-controlled analgesia pump containing 0.2% ropivacaine 150 mL, which will be infused at 2 mL/h.

In the control group, every thing will be conducted as a matter of routine without intervention.

stellate ganglion block will be administered using either 6-8mL saline (Group 1) or 0.25% ropivacaine 6-8mL (Group 2)

Stellate Ganglion Block

Xu Wang

To investigate whether stellate ganglion block is helpful to brain protection during cranial aneurysm surgery

The vasospasm after cranial aneurysm surgery have a higher incidence, but not have an ideal treatment method. At present, the medical treatment is very limited effect to prevent the perioperative cerebral ischemia.Stellate ganglion block （SGB）is an effective and well-tolerated approach to the treatment of CVS in various clinical settings.Resent study indicated that SGB has a protective effect on delayed cerebral vasospasm in an experimental rat model of subarachnoid hemorrhage.Therefore,we hypothesized that the preoperative SGB would be a effective treatment for improvement of vasospasm after cranial aneurysm surgery.

Perioperative Neuroprotection of Stellate Ganglion Block

Preventive Effect of Stellate Ganglion Block on Cerebral Vasospasm in Patients Undergoing Aneurysm Surgery

The postoperative recovery quality will be evaluated by using of the Post-operative Quality Recovery Scale (PQRS)

The occurrence of cerebral vasospasm will be diagnosed by using of the transcranial doppler instrument.

Cerebral oxygen metabolism will be monitored through jugular venous oxygen saturation (SjVO2) and cerebral extraction rate of oxygen (CERO2), and measured by blood gas analysis at each time point, the latter will be calculated using the formula:

CaO2 = (Hb\*1.38\*SaO2) + (0.003\*PaO2); CvO2 = (Hb\*1.38\*SjvO2) + (0.003\*PjvO2); CERO2 = (CaO2-CvO2)/CaO2 where CaO2 is arterial oxygen content, Hb is arterial hemoglobin concentration, SaO2 is arterial oxygen saturation, PaO2 is the arterial partial pressure of oxygen, CvO2 is mixed venous oxygen content and PjvO2 is the jugular venous partial pressure of oxygen.

A 5-mL jugular venous blood sample will be taken at each time point, centrifuged at 3,000 rpm for 25 min, and kept in a freezer at -80°C until analysis. the concentrations of plasma endothelin, melatonin, and S100-β protein will be measured using enzyme-linked immunosorbent assays.

The postoperative cognitive function will be measured by using of the mini-mental state examination (MMSE).

General Hospital of Ningxia Medical University

Hypoglycemia

Hypoglycemic Agents

Other Dietary Supplements

Insulin

Insulin, Globin Zinc

Benzocaine

Tannic Acid

change of insulin infusion every 30 minutes

Adjustable insulin infusion scale with loading doses

Dhanesh Gupta, MD

What is the efficacy and safety of q 30 minutes vs. q 1hour glucose sampling and intervention for an intensive insulin protocol to achieve and maintain euglycemia in non-diabetic patients undergoing craniotomy? The investigators hypothesize that in non-diabetic patients undergoing craniotomy, monitoring glucose and modifying insulin infusions every 30 minutes compared to every hour will help them reach target glucose levels faster and maintain them more efficiently with the same insulin protocol.

Intraoperative blood glucose levels will be maintained in the target range of 90-110 mg/dL (euglycemia) using the protocol. The target serum glucose ranges chosen (90-110 mg/dL) was chosen to specifically target those levels associated with the best outcome in cerebral aneurysm surgery (serum glucose \< 108 mg/dL) and aggressively avoid those levels associated with cognitive dysfunction (serum glucose \< 128 mg/dL) and gross neurologic deficits (serum glucose \< 152 mg/dL). Because the strength of these data, the investigators utilize an aggressive insulin protocol in their routine clinical care of patients undergoing craniotomies.

Each patient will be randomly assigned to one of two frequency of intervention groups-Group 30 will have the insulin dose adjusted every 30 minutes and Group 60 will have the insulin dose adjusted every 60 minutes. Blood glucose levels, insulin boluses and infusion rates, and dextrose boluses will be recorded on the respective Intraoperative Insulin \& Glucose data sheet (Appendix 2 and 3 for Group 30 and Group 60, respectively).

Regardless of the protocol, glucose measurements will be conducted every 15 minutes but insulin intervention will be done at 30 minutes or one hour (per assigned treatment group). The interval data (15 minutes for the 30 min group and 15, 30, and 45 minutes for the 1 hour group) will be utilized to determine the pharmacodynamic effects of insulin (dose-response relationship). Interventions will only be performed at the assigned interval (30 vs 60 min) unless the glucose level is \< 70 mg/dL, at which time the patient will receive 25 mL of 50% Dextrose solution. For these rescued patients, the protocol will be continued as scheduled.

On the day of surgery, after confirming entry into the study (i.e., confirmation of research consent), each patient will be randomly assigned to a specific protocol-q 30 minutes glucose measurements and intervention vs. q 60 minutes glucose measurements and intervention.Randomization will be performed in blocks of 10 using a computer generated random number assignment (odd numbers = q 30 minutes and even numbers = q 60 minutes)

Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia

Comparing Two Glucose Sampling Frequencies for an Intensive Insulin Protocol During Craniotomy in Non-Diabetic Patients-How Efficiently and Safely Can We Maintain Target Glucose Levels

performance of each of glucose sampling and insulin protocols for achieving euglycemia during the operation

Elapsed time required to reach euglycemia during the operation

Evaluating the relationship of BMI (Body Mass Index) and the performance of protocols during the operation

Evaluating the relationship of serum biomarkers of insulin resistance and performance of protocols during the operation

Northwestern University

Assistant Professor in Anesthesiology and Neurological Surgery

Analgesics

Dexmedetomidine

Analgesics, Opioid

Esmolol

Adrenergic Agents

Adrenergic Antagonists

Adrenergic Agonists

Adrenergic alpha-Agonists

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Neurotransmitter Agents

Adrenergic beta-1 Receptor Antagonists

Adrenergic beta-Antagonists

Esmolol 500mcg/kg before induction in anesthesia following by 300mcg/Kg/min until extubation.

Dexmedetomidine 1mcg/Kg following by 0.7mcg/Kg/h until end of surgery.

effect of esmolol on intraoperative sympathetic control and on extubation conditions.

effect of dexmedetomidine on intraoperative sympathetic control and on extubation conditions.

Irene Asouhidou, MD, PhD

Dimitris Zosimidis, MD

Patients undergoing intracranial procedures may experience severe hypertension and tachycardia due to intracranial hypertension and to increased release of adrenaline. Preventing perioperative sympathetic activity is of great importance. A common technique is using b-blockers like esmolol, which effectively block perioperative hemodynamic changes during intracranial surgery. A2 agonists, like Dexmedetomidine-Dex are now being used as a component of a balanced anesthesia during neurosurgical procedures. This study aimed to evaluate whether esmolol or dex attenuates perioperative changes in patients undergoing elective craniotomy with fast track neuroanesthesia.

Patients scheduled for elective craniotomy are randomized to receive Dex 1γ/Kg over 10 minutes following by continuous infusion of Dex 0.7γ/Kg (group D) or esmolol 500mcg/Kg over 5 min following by continuous infusion of 300mcg/Kg/min (group E). Patients in both groups are subjected to a standardized anesthesia comprising of induction with propofol, fentanyl, rocuronium, and maintained with Oxygen-air: 1/1, sevoflurane and bolus fentanyl in order to access the same level of anesthesia (BIS 40-50). The hemodynamic variables at various stages of surgery (HR-heart rate, MAP-Mean arterial pressure) and recovery characteristics are also recorded. It is also performed monitoring of cerebral oximetry (INVOS).

Esmolol Versus Dexmedetomidine During Intracranial Procedures

Comparison of Esmolol and Dexmedetomidine on Sympathetic Control During Intracranial Procedures

Status of patients during emerge from anaesthesia after intracranial surgery

George Papanicolaou Hospital

Consultant anesthesiologist

Diseases and Abnormalities at or Before Birth

Subarachnoid Hemorrhage

Arteriovenous Malformations

Congenital Abnormalities

Hemangioma

Vascular Malformations

Cardiovascular Abnormalities

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Patients receiving surgical intervention for an intracranial arterial-venous malformation.

Patients receiving surgical intervention for a ruptured intracranial aneurysm.

Patients receiving surgical intervention for an unruptured intracranial aneurysm.

Eric M Deshaies, MD

Test single nucleotide polymorphisms (SNP's) in ruptured and unruptured aneurysm tissue to identify a genetic difference between the two types of aneurysms; and to test SNP's in arteriovenous malformation tissue to identify a genetic link.

Tissue samples of intracranial arterial-venous malformations (AVM) or aneurysm and blood samples.

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
Subclavian Vein catheterization_Seldinger Vs Modified Seldinger	NCT02090010	Brain Neoplasm Intracranial An... Cerebrovascular...	Seldinger techn... Modified Seldin...	20 Years - 80 Years	Seoul National University Hospital
Perioperative Neuroprotection of Stellate Ganglion Block	NCT02275247	Intracranial An...	Stellate Gangli...	20 Years - 60 Years	General Hospital of Ningxia Medical University
Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia	NCT00993057	Brain Neoplasms Intracranial An...	Insulin	18 Years -	Northwestern University
Esmolol Versus Dexmedetomidine During Intracranial Procedures	NCT02563288	Intracranial An... Intracranial Ne...	Esmolol Dexmedetomidine	18 Years - 80 Years	George Papanicolaou Hospital
Genome-wide Analysis of Single Nucleotide Polymorphisms of Brain Arteriovenous Malformations and Cerebral Aneurysm	NCT01801488	Arteriovenous M... Intracranial An... Subarachnoid He...		18 Years - 89 Years	State University of New York - Upstate Medical University
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
Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia	NCT00993057	Brain Neoplasms Intracranial An...	Insulin	18 Years -	Northwestern University
Subclavian Vein catheterization_Seldinger Vs Modified Seldinger	NCT02090010	Brain Neoplasm Intracranial An... Cerebrovascular...	Seldinger techn... Modified Seldin...	20 Years - 80 Years	Seoul National University Hospital

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