Effect of early administration of vitamin D on clinical outcome in critically ill sepsis patients: a single centre randomized placebo controlled trial

Dr amrita bhattacharyya0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Age between 18 to 80 years
•2. Presenting to the emergency department and expected to be admitted to the ICU and survive for more than 96 hours.
•3. Meet criteria for sepsis within past 12 hours
•4. Enteral access in place to enable delivery of vitamin D or placebo and are deemed to be able to tolerate enteral drug administration

•1. History of malabsorption syndromes or currently having gastrointestinal intolerance in the form of diarrhoea, vomiting or increased naso gastric aspirates.
•2. Other trial participation,
•3. Pregnant or lactating women;
•4. Patients not deemed suitable for study participation (i.e., psychiatric disease, living remotely from the clinic, or prisoner status).
•5. Age < 18 or >=80 years
•6. Inability to obtain informed consent from patient/suitable proxy within 22 hours of new-onset severe sepsis
•7. Comfort measures, hospice, or palliative care status
•8. Documented adverse reaction to vitamin D supplementation
•Renal stones within past year
•Hypercalcemia within past year
•Baseline serum calcium >=10.5 mg/dL
•Established diagnosis of medical condition associated with high risk of hypercalcemia (e.g. metastatic cancer, sarcoidosis, multiple myeloma, primary hyperparathyroidism current hypercalcemia (albumin-corrected serum calcium > 10.8 mg/dL or ionized calcium > 5.2 mg/dL)
•9. History of therapy with high dose vitamin D3 (greater than or equal to 50,000 IU a week) to treat vitamin D deficiency, within previous 6 months
•10. Chronic dialysis;
•11. >24 hours of sepsis diagnosis

发起方

Dr amrita bhattacharyya