A Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects
Phase 2
Completed
- Conditions
- Hypocalcemia
- Registration Number
- NCT00053378
- Lead Sponsor
- Abbott
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method 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
Name Time Method
Trial Locations
- Locations (9)
St. Luke's Hospital
🇺🇸Bethlehem, Pennsylvania, United States
Merced Heart Association
🇺🇸Merced, California, United States
Central Baptist Hospital Clinical Research Center
🇺🇸Lexington, Kentucky, United States
Denver Health Medical Center
🇺🇸Denver, Colorado, United States
Outcomes Research Institute
🇺🇸Hudson, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Heart Care Associates
🇺🇸Hopewell, Virginia, United States
Strong Memorial Hospital
🇺🇸Rochester, New York, United States
Florida Hospital
🇺🇸Orlando, Florida, United States