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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00053378
First received: January 27, 2003
Last updated: July 31, 2006
Last verified: July 2006
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00053378     History of Changes
Other Study ID Numbers: M01-395
Study First Received: January 27, 2003
Last Updated: July 31, 2006
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014