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

Phase 2

Completed

• Conditions: Severe Sepsis or Septic Shock
• Interventions: Drug: Placebo; Drug: Calcitriol

• Registration Number: NCT01689441
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-18
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-21
• Study Start: 2013-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Results First Submitted: 2014-10-27
• Results First Submitted QC: 2014-10-27
• Results First Posted: 2014-10-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• age ≥ 18
• Severe sepsis or septic shock
• Central venous catheter (for blood drawing)

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Normal saline 2cc IV x 1
Calcitriol	Calcitriol	Calcitriol 2mcg IV x 1

Primary Outcome Measures

Name	Time	Method
Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours	48 hours

Secondary Outcome Measures

Name	Time	Method
Plasma Interleukin-6 (IL-6) Levels at 48 Hours	48 hours
Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) / Creatinine Ratio at 48 Hours	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States