NCT00053378

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2003

Completed
Last Updated

August 2, 2006

Status Verified

July 1, 2006

First QC Date

January 27, 2003

Last Update Submit

July 31, 2006

Conditions

Hypocalcemia

Keywords

hypocalcemia, ionized calcium, intensive care

Outcome Measures

Primary Outcomes (1)

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

Interventions

paricalcitol injection (Zemplar)DRUG
Effects on calcium regulationBEHAVIORAL
Administration of elemental Ca during hypocalcemic ICU pts.BEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Serum creatinine greater than 2.5 mg/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Merced Heart Association

Merced, California, 95340, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Outcomes Research Institute

Hudson, Florida, 34667, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Central Baptist Hospital Clinical Research Center

Lexington, Kentucky, 40503, United States

Location

Strong Memorial Hospital

Rochester, New York, 14642, United States

Location

St. Luke's Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

Heart Care Associates

Hopewell, Virginia, 23860, United States

Location

MeSH Terms

Conditions

Hypocalcemia

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Calcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Study Officials

  • Joel Z Melnick, M.D.

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 27, 2003

First Posted

January 28, 2003

Study Start

January 1, 2002

Last Updated

August 2, 2006

Record last verified: 2006-07

Locations

US(9)