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

Primary Purpose

Severe Sepsis or Septic Shock

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Calcitriol
Placebo
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis or Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Calcitriol

Placebo

Arm Description

Calcitriol 2mcg IV x 1

Normal saline 2cc IV x 1

Outcomes

Primary Outcome Measures

Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours

Secondary Outcome Measures

Plasma Interleukin-6 (IL-6) Levels at 48 Hours
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.

Full Information

First Posted
September 18, 2012
Last Updated
November 5, 2020
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01689441
Brief Title
Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis
Official Title
Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis or Septic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcitriol
Arm Type
Experimental
Arm Description
Calcitriol 2mcg IV x 1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline 2cc IV x 1
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Plasma Interleukin-6 (IL-6) Levels at 48 Hours
Time Frame
48 hours
Title
Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) / Creatinine Ratio at 48 Hours
Description
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.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E Leaf, M.D.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25029202
Citation
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.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/25029202
Description
Link to manuscript in pubmed

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

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