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

Phase 2

Completed

• Conditions: Acute Respiratory Failure; Critically Ill
• Interventions: Drug: Filgrastim

• Registration Number: NCT01713309
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1996-01
• Primary Completion: 1998-06
• Study Completion: 1998-09
• Status Verified: 2012-10
• Study First Submitted: 2012-10-14
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-24
• Last Update Submitted: 2012-10-25
• Last Update Posted: 2012-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Filgrastim	Filgrastim	Filgrastim 300 microgr/day subcutaneously for 7 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland