Outcome of High Dose Vitamin D on Prognosis of Sepsis Requiring Mechanical Ventilation; A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in procalcitonin level (ng/ml) and antimicrobial peptide cathelicidin (LL37) (ng/ml) level at day 7.
研究概览
简要总结
There is a high prevalence of vitamin D deficiency in the critically ill patient population, with approximately 60% of patients found to be vitamin D deficient, (25(OH)D concentrations <20 ng/mL) and an additional 30% of patients being vitamin D insufficient, (25(OH)D = 20-30 ng/mL).Approximately 80% of sepsis/septic shock patients experience respiratory failure and require mechanical ventilation. Furthermore, several studies document that vitamin D deficiency could be associated with poor outcomes in critically ill patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Diagnosed with sepsis and required mechanical ventilation (MV) within 24 hours from ICU admission.
- •Expected to require mechanical ventilation for at least 72 hours after study entry.
排除标准
- •Age <18 years.
- •inability to obtain informed consent from the patient and/or legally authorized representative.
- •Pregnant or breastfeeding.
- •Chronic kidney diseases
- •Pancreatitis.
- •Hepatic insufficiency
- •Cases with coagulopathy
- •Moribund and not expected to survive 96 hours.
- •Ongoing shock
- •History of therapy with high dose vitamin D3 within previous 6 months.
- •History of disorders associated with hypercalcemia
- •Cancer as the cause of sepsis.
- •Subjects undergoing chemotherapy.
- •Immune compromised patients.
- •Pneumonia developed < 48 hours following intubation.
- •Patients with history of aspiration before intubation.
- •known allergy to vitamin D.
研究组 & 干预措施
Group 1(Treatment group)
干预措施: Vitamin D3 tablets (Drug)
Group 2(Control group)
干预措施: Vitamin D tablets (Drug)
结局指标
主要结局
Change in procalcitonin level (ng/ml) and antimicrobial peptide cathelicidin (LL37) (ng/ml) level at day 7.
时间窗: 7 days
Change in procalcitonin level (ng/ml) and antimicrobial peptide cathelicidin (LL37) (ng/ml) level at day 7.
次要结局
未报告次要终点
研究者
Dr.Ibrahim Mamdouh Esmat
Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.
Ain Shams University