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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:
ClinicalTrials.gov Identifier:
NCT00053378
First Posted: January 28, 2003
Last Update Posted: August 2, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  Purpose
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 Intervention Phase
Hypocalcemia Drug: paricalcitol injection (Zemplar) Behavioral: Effects on calcium regulation Behavioral: Administration of elemental Ca during hypocalcemic ICU pts. Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

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.

Estimated Enrollment: 45
Study Start Date: January 2002
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053378


Locations
United States, California
Merced Heart Association
Merced, California, United States, 95340
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
United States, Florida
Outcomes Research Institute
Hudson, Florida, United States, 34667
Florida Hospital
Orlando, Florida, United States, 32803
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Kentucky
Central Baptist Hospital Clinical Research Center
Lexington, Kentucky, United States, 40503
United States, New York
Strong Memorial Hospital
Rochester, New York, United States, 14642
United States, Pennsylvania
St. Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
United States, Virginia
Heart Care Associates
Hopewell, Virginia, United States, 23860
Sponsors and Collaborators
Abbott
Investigators
Study Director: Joel Z Melnick, M.D. Abbott
  More Information

ClinicalTrials.gov Identifier: NCT00053378     History of Changes
Other Study ID Numbers: M01-395
First Submitted: January 27, 2003
First Posted: January 28, 2003
Last Update Posted: August 2, 2006
Last Verified: July 2006

Keywords provided by Abbott:
hypocalcemia, ionized calcium, intensive care

Additional relevant MeSH terms:
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs