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NCT00053378 Clinical Trial

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

Hypocalcemia Clinical Trial

Official title:
A Placebo-Controlled, Double-Blind Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00053378
Other study ID # M01-395
Secondary ID
Status Completed
Phase Phase 2
First received January 27, 2003
Last updated July 31, 2006
Start date January 2002

Study information
Verified date July 2006
Source Abbott
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• paricalcitol injection (Zemplar)

Behavioral:
• Effects on calcium regulation

• Administration of elemental Ca during hypocalcemic ICU pts.

Locations
Country Name City State
United States St. Luke's Hospital Bethlehem Pennsylvania
United States University of Chicago Chicago Illinois
United States Denver Health Medical Center Denver Colorado
United States Heart Care Associates Hopewell Virginia
United States Outcomes Research Institute Hudson Florida
United States Central Baptist Hospital Clinical Research Center Lexington Kentucky
United States Merced Heart Association Merced California
United States Florida Hospital Orlando Florida
United States Strong Memorial Hospital Rochester New York

Sponsors (1)
Lead Sponsor Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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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