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

Severe Sepsis or Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01689441
• Other study ID #: 2012P001755
• Status: Completed
• Phase: Phase 2
• Start date: February 2013
• Est. completion date: February 2014

Study information

• Verified date: November 2020
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis or Septic Shock
• Toxemia

Intervention

Drug:
• Calcitriol

• Placebo

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Leaf DE, Raed A, Donnino MW, Ginde AA, Waikar SS. Randomized controlled trial of calcitriol in severe sepsis. Am J Respir Crit Care Med. 2014 Sep 1;190(5):533-41. doi: 10.1164/rccm.201405-0988OC. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours		48 hours
Secondary	Plasma Interleukin-6 (IL-6) Levels at 48 Hours		48 hours
Secondary	Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) / Creatinine Ratio at 48 Hours	NGAL is a urinary marker of renal tubular injury. NGAL levels were normalized to the urinary creatinine concentration to account for the influence of dilution on biomarker concentrations.	48 hours

External Links

•   Link to manuscript in pubmed