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

Helsinki University Central Hospital (HUCH)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Critically Ill

Acute Respiratory Failure

Treatments

Drug: Filgrastim

Study type

Interventional

Funder types

Other

Identifiers

NCT01713309

HBP01

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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