Cholecalciferol Supplementation in Critically Ill Patients With Severe Vitamin D Deficiency in Intensive Care Unit- A Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Reduction in hospital mortality
研究概览
简要总结
The purpose of the research study is to determine whether a single high dose of vitamin D is helpful in reducing critical illness related complications in intensive care patients who are having sever vitamin D deficiency.
Vitamin D deficiency is quite common in critically ill patients ranging from 81.5% to 99%. A number of scientific studies have documented a strong correlation between low levels of vit.D and increased rate of adverse outcomes including infection, acute kidney injury and mortality in ICU patients. A recent randomized controlled trial (RCT) has demonstrated a 50% reduction in hospital mortality in severe vit.D deficient patients following a single high dose of cholecalciferol (Vitamin D3). However, the role of Vit.D supplementation to boost up host immune system and eventually reduction of mortality has yet to be determined by large randomized controlled trials in humans. Hence the study aims to run a randomized controlled trial (RCT) in order to study the role of Vitamin D in critically ill patients.
详细描述
DETAILED DESCRIPTION
Introduction: Vitamin D is a fat soluble vitamin and it affects multiple systems of our body. It not only plays a key role in musculoskeletal system but also works on our immune and cardiovascular systems. Because of its wide range of anti-inflammatory and metabolic properties, vitamin D, recently, has gained an immense importance among the intensivists.
Most of the critically ill patients have vitamin D deficiency and are at high risk of complications ranging from systemic inflammatory response syndrome (SIRS), sepsis, septic shock, multi-organ dysfunction, multi-organ failure and finally death. Immune system dysregulation has been thought to play a pivotal role in the development of sepsis. Onset and progression of sepsis are dependent upon a fine balance between pro-inflammatory and anti-inflammatory mediators of the immune system. Massive and uncontrolled release of pro-inflammatory cytokines leads to widespread tissue damage and multi-organ failure. It has been found that the cells of the immune system (both innate and acquired) express receptors for vitamin D. Low levels of it renders the immune system regulatory cells dysfunctional and in turn, increases the risk of infections and other adverse outcomes. It has been estimated that even with optimal treatment anywhere from 16% to more than 80% of patients with sepsis don't survive.
To improve the survival of critically ill patients, several research studies have been focused on the identification of various biomarkers and their correlation with disease severity. Timely supplementation of cholecalciferol has been demonstrated as one of the mortality reduction interventions. In recent studies, vitamin D has been identified as an important regulator of our immune system and its deficiency is quite common in ICU patients ranging from 81.5% to 99%.
A number of scientific studies have documented a strong correlation between low levels of vit.D and increased rate of adverse outcomes including infection with multi drug resistant organisms, acute kidney injury, decreased left ventricular ejection fraction and mortality in ICU patients. It has been found that the emergence of acinetobacter baumannii infections in significantly more common in vit D deficient critically ill patients and vit D deficiency is an independent risk factor for the development of Acinetobacter baumannii infections in intensive care unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older.
- •Both male and female
- •Within 24 hours from admission.
- •Having 25 -Hydroxyvitamin D level of 12 ng/ml or lower.
- •Exclusion Criteria
- •Pregnant or lactating females.
- •Do not resuscitate (DNR) status or comfort measures only
- •Severely impaired gastrointestinal functions (e.g, paralytic ileus, continuous nasogastric tube drainage, strict nil per oral- no medication, malabsorption syndrome, chronic diarrhea etc)
- •History of renal stones within past year
- •Past history of hypercalcemia, tuberculosis or sarcoidosis.
- •Baseline serum total calcium ≥10.6 mg/dl or ionized serum calcium ≥ 5.4 mg/dl.
排除标准
- 未提供
研究组 & 干预措施
Cholecalciferol
This group of patients will receive single high dose of vitamin D (Cholecalciferol) dissolved in 45 ml of fresh milk (Nestle)
干预措施: Cholecalciferol (Drug)
Placebo
This group of patients will receive placebo - 45 ml of fresh milk (Nestle) so that the amount, color, smell, taste etc will be the same as that of experimental drug)
干预措施: Milk (Nestle) (Other)
结局指标
主要结局
Reduction in hospital mortality
时间窗: 28 days
as assessed by hospital mortality rate
次要结局
- Hospital length of stay(28 days)
- Vasopressor requirement(28 days)
- New onset of Acute kindney injury(28 days)
- Upper and lower GI bleeding(28 days)
- Emergence of Multidrug resistant (MDR) organisms(28 days)
- ICU length of stay(28 days)
- Acute co-morbidities(28 days)
- Ventilator free days(28 days)
- Development of acute CVA(28 days)
研究者
Asiah Rugaan
Consultant and Head of Department - Intensive Care Unit
King Abdullah Medical City