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

NCT ID: NCT00053378

Last Updated: 2006-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Hypocalcemia

Keywords

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hypocalcemia, ionized calcium, intensive care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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paricalcitol injection (Zemplar)

Intervention Type DRUG

Effects on calcium regulation

Intervention Type BEHAVIORAL

Administration of elemental Ca during hypocalcemic ICU pts.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Principal Investigators

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Joel Z Melnick, M.D.

Role: STUDY_DIRECTOR

Abbott

Locations

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Merced Heart Association

Merced, California, United States

Site Status

Denver Health Medical Center

Denver, Colorado, United States

Site Status

Outcomes Research Institute

Hudson, Florida, United States

Site Status

Florida Hospital

Orlando, Florida, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Central Baptist Hospital Clinical Research Center

Lexington, Kentucky, United States

Site Status

Strong Memorial Hospital

Rochester, New York, United States

Site Status

St. Luke's Hospital

Bethlehem, Pennsylvania, United States

Site Status

Heart Care Associates

Hopewell, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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M01-395

Identifier Type: -

Identifier Source: org_study_id