A 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

Completed

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Key information

Conditions

Hypocalcemia Calcium Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Merced Heart Association, Merced, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paricalcitol injection (Zemplar)

Drug

Effects on calcium regulation

Behavioral

Administration of elemental Ca during hypocalcemic ICU pts.

Behavioral

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start: 2002
First posted: Jan 28, 2003
Registry last updated: Aug 2, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed