Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Observational studies among critically ill patients have shown strong associations between vitamin D deficiency and adverse outcomes, including increased length of stay, infection, and mortality. It is unknown whether vitamin D deficiency contributes directly to adverse outcomes or whether it is simply a biomarker of severity of illness or overall health status. However, vitamin D plays a key role in host defense, largely by stimulating production of the anti-microbial peptide cathelicidin (LL-37). We will test the hypothesis that administration of activated vitamin D (calcitriol) will increase serum levels of cathelicidin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Calcitriol

Criteria

Inclusion Criteria:

• age ≥ 18

• Severe sepsis or septic shock

• Central venous catheter (for blood drawing)

Exclusion Criteria:

• Serum calcium ≥ 10.0 mg/dl or phosphate ≥ 6.0 mg/dl, assessed within previous 48 hours

• Current or recent therapy (within previous 7 days) with nutritional vitamin D at doses >1,000 I.U. per day or activated vitamin D at any dose

• History of solid organ or bone marrow transplant, primary parathyroid disease, metabolic bone disease, or sarcoidosis

• Expected to die or leave the ICU within 48 hours

• History of hypersensitivity or any allergic reaction to calcitriol

• End stage renal disease

• Acute Kidney Injury receiving intermittent renal replacement therapy

• Enrolled in a competing study

• Pregnancy