Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2014 |
| Start Date: | February 2013 |
| End Date: | May 2014 |
| Contact: | David E Leaf, M.D. |
| Email: | DELEAF@partners.org |
| Phone: | 617-732-5951 |
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.
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.
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
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