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

July 31, 2006 updated by: Abbott

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Merced, California, United States, 95340
        • Merced Heart Association
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health Medical Center
    • Florida
      • Hudson, Florida, United States, 34667
        • Outcomes Research Institute
      • Orlando, Florida, United States, 32803
        • Florida Hospital
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Central Baptist Hospital Clinical Research Center
    • New York
      • Rochester, New York, United States, 14642
        • Strong Memorial Hospital
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Hospital
    • Virginia
      • Hopewell, Virginia, United States, 23860
        • Heart Care Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary efficacy variable will be the change from Day 1 to last day of dosing in pH adjusted, serum ionized calcium levels.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Joel Z Melnick, M.D., Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Study Registration Dates

First Submitted

January 27, 2003

First Submitted That Met QC Criteria

January 27, 2003

First Posted (ESTIMATE)

January 28, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

August 2, 2006

Last Update Submitted That Met QC Criteria

July 31, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M01-395

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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