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)

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01713309

Acronym

HBP-Neupogen

Enrollment

Registered

2012-10-24

Start date

1996-01-31

Completion date

1998-09-30

Last updated

2012-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure, Critically Ill

Keywords

Filgrastim, G-CSF, Heparin-binding protein, critically ill, acute respiratory failure

Brief 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.

Interventions

DRUGFilgrastim

Filgrastim 300 ug daily for 7 days, subcutaneously.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Number of adverse events	up to 28 days	the number of patients developing ARDS, disseminated intravascular coagulation or acute renal failure during days 1-28, and changes in MOD score during days 1-7.

Secondary

Measure	Time frame	Description
follow up measures	Up to day 90	frequency of nosocomial infections, length of mechanical ventilatory support, length of stay in the ICU, 28-day mortality rate, 90-day mortality rate, and laboratory values for neutrophil count

Other

Measure	Time frame	Description
inflammatory mediators	up to day 7	cytokines, IL-6, TNF, phospolipase A2 and BPIP (=bacterial permeability increasing protein)

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026