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

Abbott

Status and phase: Completed; Phase 2

Conditions: Hypocalcemia

Treatments: Behavioral: Effects on calcium regulation; Drug: paricalcitol injection (Zemplar); Behavioral: Administration of elemental Ca during hypocalcemic ICU pts.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00053378

M01-395

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind