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A Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00053378
First received: January 27, 2003
Last updated: July 31, 2006
Last verified: July 2006

January 27, 2003
July 31, 2006
January 2002
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The primary efficacy variable will be the change from Day 1 to last day of dosing in pH adjusted, serum ionized calcium levels.
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Complete list of historical versions of study NCT00053378 on ClinicalTrials.gov Archive Site
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A Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects
A Placebo-Controlled, Double-Blind Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects

A study to determine the effect of Zemplar on the regulation of serum calcium levels and the need for administration of elemental calcium in hypocalcemic intensive care patients

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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypocalcemia
  • Drug: paricalcitol injection (Zemplar)
  • Behavioral: Effects on calcium regulation
  • Behavioral: Administration of elemental Ca during hypocalcemic ICU pts.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
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Inclusion Criteria:

  • ICU patients APACHE III score between 70 - 150 at screening and within 24 hours of enrollment and a whole blood ionized calcium level less than 0.90 mmol/L or corrected whole blood calcium level less than or equal to 7.5 mg/dL.

Exclusion Criteria:

  • Serum creatinine greater than 2.5 mg/dL
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00053378
M01-395
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Abbott
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Study Director: Joel Z Melnick, M.D. Abbott
Abbott
July 2006

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