Heparin Binding Protein in Patients With Acute Respiratory Failure Treated With GCSF (Filgrastim)

• Status: Completed
• Trial end date: 1998-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study of plasma HBP -levels of a previously published trial of G-CSF in critically ill patients (Pettila et al. Critical Care Medicine 2000). The original study was a prospective, randomised, double-blind, placebo-controlled trial of filgrastim in patients with acute respiratory failure requiring intubation. In this substudy, the investigators evaluated the effect of filgrastim on HBP -concentrations in critically ill patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helsinki University Central Hospital
• Collaborator: The Swedish Research Council
• Treatments: Antimicrobial Cationic Peptides; Calcium heparin; Heparin; Lenograstim

Criteria

Criteria for original study. For the substudy, all these patients were included.

Inclusion Criteria:

• Age > 18 years

• Admitted to the ICU no longer than 12 hrs before study entry

• Intubated because of ventilation insufficiency no longer than 48 hrs before study entry

• Clinically expected stay in the ICU > 48 hrs

• Informed consent

Exclusion Criteria:

• Pregnant or nursing

• Total leukocyte count of > 50,000/mm3

• Administration of filgrastim, sargramostim, or other biological response modifiers within 7 days before study entry

• Known hypersensitivity or allergic reaction to Escherichia coli-derived products

• Participation in another drug study