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

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ClinicalTrials.gov Identifier: NCT01689441
Recruitment Status : Completed
First Posted : September 21, 2012
Results First Posted : October 30, 2014
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Sushrut S Waikar, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE September 18, 2012
First Posted Date  ICMJE September 21, 2012
Results First Submitted Date  ICMJE October 27, 2014
Results First Posted Date  ICMJE October 30, 2014
Last Update Posted Date September 15, 2016
Study Start Date  ICMJE February 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours [ Time Frame: 48 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2012)
Change in serum cathelicidin levels [ Time Frame: 48 hours ]
Change History Complete list of historical versions of study NCT01689441 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
  • Plasma Interleukin-6 (IL-6) Levels at 48 Hours [ Time Frame: 48 hours ]
  • Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) / Creatinine Ratio at 48 Hours [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2012)
  • Change in plasma inflammatory biomarkers [ Time Frame: 48 hours ]
  • Change in plasma and urinary biomarkers of acute kidney injury [ Time Frame: 48 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis
Official Title  ICMJE Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Severe Sepsis or Septic Shock
Intervention  ICMJE
  • Drug: Calcitriol
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Calcitriol
    Calcitriol 2mcg IV x 1
    Intervention: Drug: Calcitriol
  • Placebo Comparator: Placebo
    Normal saline 2cc IV x 1
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2014)
67
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01689441
Other Study ID Numbers  ICMJE 2012P001755
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sushrut S Waikar, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David E Leaf, M.D. Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP