Atorvastatin 40mg once daily orally for 8 weeks starting 2 weeks before AVF creation

1 tablet once daily orally for 8 weeks starting 2 weeks before AVF creation

Primary Arteriovenous Fistula Failure

one 40mg tablet daily for 8 weeks starting 2 weeks before the AVF creation.

Atorvastatin 40mg

one tablet daily for 8 weeks starting 2 weeks before the AVF creation.

Placebo

Albany Medical College

High-intensity Atorvastatin for Arteriovenous Fistula Failure (HAFF): A Feasibility Pilot Study

The patient recruitment rate (in percent) is an important parameter to evaluate the feasibility of the study and to plan future Phase II trials.

The patient retention rate (in percent) is an important parameter to evaluate the feasibility of the study and to plan future Phase II trials.

The patient compliance (in percent) is an important parameter to evaluate the feasibility of the study and to plan future Phase II trials.

The rate of adverse events (in percent) is an important parameter to evaluate the safety of the study and it is important to plan future Phase II trials.

The predictive measurement of AVF blood flow (in milliliter per minute) 6 weeks after fistula creation is useful for the estimation of the probable effect of proposed intervention in order to better assess the sample size for subsequent RCT.

The predictive measurements of diameter (in millimeters) 6 weeks after fistula creation is useful for the estimation of the probable effect of proposed intervention in order to better assess the sample size for subsequent RCT.

No personal data will be transfer outside AMC. Study paper records, computer files, and communications will be appropriately safeguarded by study personnel and the IT department from unauthorized access. Name or any other data that might identify patients will not be used in any reports or publications resulting from this study. Password-protected computers will be utilized, and the identity of subjects will be maintained separately from computerized data forms. Only the primary investigator and members of the research team who contact the subjects will have access to collected information in a need to know basis. All clinical data and biological specimens obtained will be linked to the individual subject by only a unique study identification code (master-key). The PI will keep the master-key secure and confidential in his office, and only he and the CRC will have access to the master-key.

Loay Salman, MD

Professor of Medicine

Patients on deep brain stimulation for either obsessive-compulsive disorder or major depression, undergoing rechargeable neurostimulator implantation as intervention

Obsessive-compulsive Disorder

Depression

Rechargeable neurostimulators are implanted when the non-rechargeable neurostimulators are end-of-life.

Medtronic Restore Advanced 37713

Rechargeable Neurostimulators in Deep Brain Stimulation for Psychiatric Disorders

Feasibility Study Regarding the Implantation and Use of Rechargeable Neurostimulators in Deep Brain Stimulation for Psychiatric Disorders (Either Obsessive-compulsive Disorder or Major Depression)

Change in mean Yale‐Brown Obsessive Compulsive Scale (Y‐BOCS). Mean Y-BOCS during the first 2 years after intervention minus mean Y-BOCS during the last 2 years before intervention.

Change in Hamilton Depression Rating Scale (HAM‐D). Mean HAM-D during the first 2 years after intervention minus mean HAM-D during the last 2 years before intervention.

Change in Beck Depression Inventory (BDI). Mean BDI during the first 2 years after intervention minus mean BDI during the last 2 years before intervention.

Change in Global Assessment of Functioning (GAF). Mean GAF during the first 2 years after intervention minus mean GAF during the last 2 years before intervention.

Change in Stimulation amplitude as measured in volt. Mean stimulation amplitude during the first 2 years after intervention minus mean stimulation amplitude during the last 2 years before intervention.

Change in Stimulation frequency as measured in hertz Mean stimulation frequency during the first 2 years after intervention minus mean stimulation frequency during the last 2 years before intervention

Stimulation pulse width as measured in seconds. Mean stimulation pulse width during the first 2 years after intervention minus mean stimulation pulse width during the last 2 years before intervention.

Change in stimulation contact configuration as expressed in fraction of patients using a certain contact point as anode or cathode.
Fraction of patients using a certain contact point as cathode or anode during the first 2 years after intervention minus fraction of patients using a certain contact point as cathode or anode during the last 2 years before intervention.

Change in frequency of outpatient clinic contacts at the Psychiatry department. Frequency of outpatient clinic contacts at the Psychiatry department during the first 2 years after intervention minus frequency of outpatient clinic contacts at the Psychiatry department during the last 2 years before intervention.

Change in fraction of hospitalized days at the Psychiatry department. Fraction of hospitalized days at the Psychiatry department during the first 2 years after intervention minus fraction of hospitalized days at the Psychiatry department during the last 2 years before intervention.

Change in frequency of outpatient clinic contacts at the Neurosurgery department.
Frequency of outpatient clinic contacts at the Neurosurgery department during the first 2 years after intervention minus frequency of outpatient clinic contacts at the Neurosurgery department during the last 2 years before intervention.

Change in fraction of hospitalized days at the Neurosurgery department. Fraction of hospitalized days at the Neurosurgery department during the first 2 years after intervention minus fraction of hospitalized days at the Neurosurgery department during the last 2 years before intervention.

Change in frequency of neurosurgical procedures related to the DBS system. Frequency of neurosurgical procedures related to the DBS system after intervention minus frequency of neurosurgical procedures related to the DBS system before intervention.

Universitaire Ziekenhuizen Leuven

Medtronic

This group will receive daily cholecalciferol (vitamin D3) based on the Adequate Intake (AI) for infants and the Recommended Dietary Allowance (RDA) for children over 1 year. Specific dose amounts are 400 IU per day for infants (0-1 year), and 600 IU per day for children between 1-17 years. Infants under 12 months of age who are formula fed will be given a placebo solution.

This group will receive cholecalciferol (vitamin D3) based on the age-specific tolerable daily upper intake level (UL). Specific dose amounts are 1600 IU per day for infants (0-1 year), and 2400 IU per day for children between 1-17 years. Infants under 12 months of age who are formula fed will be given a dose of 1200 IU per day to account for vitamin D in formula.

Usual Care Group

This group will receive cholecalciferol (vitamin D3) based on the age-specific tolerable daily upper intake level (UL). Specific dose amounts are 1600 IU per day for infants (0-1 year), and 2400 IU per day for children between 1-17 years. Infants under 12 months of age who are formula fed will be given a dose of 1200 IU per day to account for vitamin D in formula.
Cholecalciferol: The High Dose group is based on the age-specific UL. These doses were chosen to elevate 25OHD well above 50 nmol/L, while minimizing the risk of vitamin D toxicity (e.g. hypercalcemia, hypercalciuria)

High Dose Group

Total

Sex: Female, Male

Weight (kg)

The Risk Adjustment in Congenital Heart Surgery (RACHS) allows a detailed understanding of differences in mortality among pediatric patients who are undergoing surgery for congenital heart disease (CHD). Patients are assigned to to one of 6 risk categories (Risk Category 1 to Risk Category 6) based on the type of cardiac procedures. The risk categories group cardiac procedures with similar risks for in-hospital death together. A higher risk category means a higher risk of in-hospital death.

RACHS Score

Other active medical condition

Surgery season

Ethnicity

Expected Duration to Surgery at Time of Enrolment

Type of Feeding in Children <1 year

Blood 25OHD will be measured to determine vitamin D deficiency, with a concentration below 50 nmol/L used to define deficiency. A PICU admission blood sample could not be obtained for one patient in the Usual Care Group and one patient in the High Dose Group, thus the total number analyzed differs from the full sample size.

Blood 25 Hydroxyvitamin D (25OHD) Concentrations

Hypercalcemia will be defined as an ionized calcium level above 1.40 mmol/L; or above 1.45 mmol/L for children under 8 weeks. Hypercalcemia will be evaluated in blood collected immediately before CHD surgery and throughout the post-operative course (measurements are standard of care).

Number of Participants With Hypercalcemia as a Vitamin D Related Adverse Event

Hypercalciuria will be identified using calcium:creatinine ratios defined using age-specific norms and thresholds.

Number of Participants With Hypercalciuria

Impaired vitamin D axis function will be defined as an inability to restore and maintain active hormone levels in the normal range following surgery after the first post-operative day

Vitamin D Parathyroid Renal Axis Function Through Changes in Blood 1,25-dihydroxycholecalciferol

Changes in Cathelicidin as Measure of Innate Immune Function

Primarily, post-operative catecholamine requirements during the PICU admission will be evaluated as a dichotomous variable (yes/no). If a difference is noted in the primary analysis, inotrope requirements will be determined using the inotrope score, evaluated as the maximum score and in a time to event approach (off all inotropes, score of zero)

Post-operative PICU Catecholamine Requirements

The post-operative day 1 echocardiogram will be used to evaluate for differences in cardiovascular function between study arms.

Cardiovascular Function Through an Echocardiogram

Overall Study

Katie O'Hearn, PICU Research Coordinator

Vitamin D Deficiency

Thoracic Surgery

Pediatric Disorders

Heart Defects, Congenital

The High Dose group is based on the age-specific UL. These doses were chosen to elevate 25OHD well above 50 nmol/L, while minimizing the risk of vitamin D toxicity (e.g. hypercalcemia, hypercalciuria)

Cholecalciferol

Children's Hospital of Eastern Ontario

Prevention of Vitamin D Deficiency Following Pediatric CHD Surgery: a Phase II Dose Evaluation Randomized Controlled Trial Comparing Usual Care With a High Dose Pre-operative Supplementation Regimen Based on the Institute of Medicine Daily Upper Tolerable Intake Level

Prevention of Post-Cardiac Surgery Vitamin D Deficiency in Children With Congenital Heart Disease: A Pilot Dose Evaluation Randomized Controlled Trial

James Dayre McNally

Dr. James Dayre McNally, Pediatric Intensivist, Department of Pediatrics, CHEO, Associate Investigator, CHEO Research Institute

The Ottawa Hospital

McGill University

Children's University Hospital, Ireland

Ottawa Hospital Research Institute

A subset of individuals started the study period taking monotherapy with simvastatin. After a 12-week period, ezetimibe was combined to the initial monotherapy for more 12 weeks (combination period = experimental).

A subset of individuals started the study period taking monotherapy with ezetimibe. After a 12-week period, simvastin was combined to the initial monotherapy for more 12 weeks (combination period = experimental).

To each subset of individuals which started the study period taking monotherapy with simvastatin or ezetimibe (active comparators), the other drug (ezetimibe or simvastatin, respectively) was combined for more 12 weeks (combination period = experimental arm).

Prediabetes

Hypercholesterolemia

Inflammation

Cardiovascular Risk

Tablets of simvastatin 20 mg administered once a day for 12 weeks

Simvastatin

Tablets of ezetimibe 10 mg administered once a day for 12 weeks

Ezetimibe

Simvastatin 20 mg, once a day, was administered for an additional 12-week period for the subset of individuals who took the initial monotherapy with ezetimibe 10 mg (12 week duration).
Ezetimibe 10 mg, once a day, was administered for an additional 12-week period for the subset of individuals who took the initial monotherapy with simvastatin 20 mg (12 week duration).
This Combination represents the experimental period of the present study.

Combination Simvastatin plus Ezetimibe

Article in press in Metabolism Clinical and Experimental: doi: 10.1016/j.metabol.2010.02.011

Hospital do Rim e Hipertensao da UNIFESP

Effect of Simvastatin and Ezetimibe on Lipid and Inflammation

Synergistic Effect of Simvastatin and Ezetimibe on Lipid and Pro-inflammatory Profiles in Pre-diabetic Subjects

CRP is one of the most important inflammatory marker and its determination has been considered a non-traditional risk factor for several chronic diseases including diabetes and cardiovascular diseases.

Interleukin-6 (IL-6) is a cytokine also produced by the adiposo tissue; its measurement in blood has been used as inflammatory marker for research purposes.

Tumor necrosis factor alfa (TNF-alpha) is secreted by adipose tissue and released to blood. Circulating levels of TNF-alpha may be indicative of a proinflammatory status, which is a initiating mechanism of metabolic and cardiovascular abnormalities.

nterleukin-6 (IL-6) is a cytokine also produced by the adiposo tissue; its measurement in blood has been used as inflammatory marker for research purposes.

creatine/karijes

High-intensity Atorvastatin for Arteriovenous Fistula Failure (HAFF): A Feasibility Pilot Study

Rechargeable Neurostimulators in Deep Brain Stimulation for Psychiatric Disorders

Prevention of Vitamin D Deficiency Following Pediatric CHD Surgery: a Phase II Dose Evaluation Randomized Controlled Trial Comparing Usual Care With a High Dose Pre-operative Supplementation Regimen Based on the Institute of Medicine Daily Upper Tolerable Intake Level

Effect of Simvastatin and Ezetimibe on Lipid and Inflammation

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