Trial | NCT01713309  Report issue

Title

Heparin Binding Protein in Patients With Acute Respiratory Failure Treated With GCSF (Filgrastim)
Heparin Binding Protein in Patients With Acute Respiratory Failure Treated With Granulocyte Colony-stimulating Factor (Filgrastim)

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    59
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.
Study Started
Jan 31
1996
Primary Completion
Jun 30
1998
Study Completion
Sep 30
1998
Last Update
Oct 29
2012
Estimate

Drug Filgrastim

Filgrastim 300 ug daily for 7 days, subcutaneously.

  • Other names: Neupogen

Filgrastim Active Comparator

Filgrastim 300 microgr/day subcutaneously for 7 days

NaCl 0.9% Placebo Comparator

Corresponding placebo once daily, subcutaneously for 7 days

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
No Results Posted