A Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects
Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00053378
Collaborator
(none)
45
9
5
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Placebo-Controlled, Double-Blind Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects
Study Start Date
:
Jan 1, 2002
Outcome Measures
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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Merced Heart Association | Merced | California | United States | 95340 |
| 2 | Denver Health Medical Center | Denver | Colorado | United States | 80204 |
| 3 | Outcomes Research Institute | Hudson | Florida | United States | 34667 |
| 4 | Florida Hospital | Orlando | Florida | United States | 32803 |
| 5 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 6 | Central Baptist Hospital Clinical Research Center | Lexington | Kentucky | United States | 40503 |
| 7 | Strong Memorial Hospital | Rochester | New York | United States | 14642 |
| 8 | St. Luke's Hospital | Bethlehem | Pennsylvania | United States | 18015 |
| 9 | Heart Care Associates | Hopewell | Virginia | United States | 23860 |
Sponsors and Collaborators
- Abbott
Investigators
- Study Director: Joel Z Melnick, M.D., Abbott
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00053378
Other Study ID Numbers:
- M01-395
First Posted:
Jan 28, 2003
Last Update Posted:
Aug 2, 2006
Last Verified:
Jul 1, 2006
Keywords provided by ,
,
Additional relevant MeSH terms: