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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Respiratory Failure, Critically Ill

Intervention / Treatment
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* Drug: Filgrastim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Filgrastim<br>Filgrastim 300 microgr/day subcutaneously for 7 days | Drug: Filgrastim<br>* Filgrastim 300 ug daily for 7 days, subcutaneously.<br>* Other names: Neupogen;|
| Placebo Comparator: NaCl 0.9%<br>Corresponding placebo once daily, subcutaneously for 7 days | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | 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. | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| follow up measures | 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 | Up to day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Filgrastim, G-CSF, Heparin-binding protein, critically ill, acute respiratory failure