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

This study has been completed.

First Received: January 27, 2003 Last Updated: July 31, 2006 History of Changes

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00053378

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Calcium

Drug Information available for: 19-Nor-1alpha,25-dihydroxyvitamin D2 Calcium gluconate

U.S. FDA Resources

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

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

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

Keywords provided by Abbott:

hypocalcemia, ionized calcium, intensive care

Additional relevant MeSH terms:

Calcium Metabolism Disorders
Calcium, Dietary
Hypocalcemia
Metabolic Diseases

Physiological Effects of Drugs
Bone Density Conservation Agents
Water-Electrolyte Imbalance
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009