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

Helsinki University Central Hospital59 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Acute Respiratory Failure Critically Ill

Interventions

FilgrastimDRUG

Filgrastim 300 ug daily for 7 days, subcutaneously.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Helsinki University Central Hospital

Helsinki, Finland

Outcomes

Primary Outcomes

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.

Time frame: up to 28 days

Secondary Outcomes

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

Time frame: Up to day 90

Data from ClinicalTrials.gov

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