Back to resultsA Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects
Primary Purpose
Hypocalcemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
paricalcitol injection (Zemplar)
Effects on calcium regulation
Administration of elemental Ca during hypocalcemic ICU pts.
Sponsored by
About this trial
This is an interventional treatment trial for Hypocalcemia focused on measuring hypocalcemia, ionized calcium, intensive care
Eligibility Criteria
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
Sites / Locations
- Merced Heart Association
- Denver Health Medical Center
- Outcomes Research Institute
- Florida Hospital
- University of Chicago
- Central Baptist Hospital Clinical Research Center
- Strong Memorial Hospital
- St. Luke's Hospital
- Heart Care Associates
Outcomes
Primary Outcome Measures
The primary efficacy variable will be the change from Day 1 to last day of dosing in pH adjusted, serum ionized calcium levels.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00053378
Brief Title
A Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects
Official Title
A Placebo-Controlled, Double-Blind Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypocalcemia
Keywords
hypocalcemia, ionized calcium, intensive care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
45 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
paricalcitol injection (Zemplar)
Intervention Type
Behavioral
Intervention Name(s)
Effects on calcium regulation
Intervention Type
Behavioral
Intervention Name(s)
Administration of elemental Ca during hypocalcemic ICU pts.
Primary Outcome Measure Information:
Title
The primary efficacy variable will be the change from Day 1 to last day of dosing in pH adjusted, serum ionized calcium levels.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Z Melnick, M.D.
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Merced Heart Association
City
Merced
State/Province
California
ZIP/Postal Code
95340
Country
United States
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Outcomes Research Institute
City
Hudson
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Central Baptist Hospital Clinical Research Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
St. Luke's Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Heart Care Associates
City
Hopewell
State/Province
Virginia
ZIP/Postal Code
23860
Country
United States
12. IPD Sharing Statement
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A Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects
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