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NCT Number: NCT01713309

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

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.

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Key information

Conditions

Acute Respiratory Failure Critical Illness Critically Ill Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Helsinki University Central Hospital

Helsinki, 00029, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Filgrastim

Drug

Filgrastim 300 ug daily for 7 days, subcutaneously.

Other names: Neupogen

Primary outcomes

  1. Number of adverse events

    Time frame: 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 outcomes

  1. follow up measures

    Time frame: 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 outcomes

  1. inflammatory mediators

    Time frame: up to day 7

    cytokines, IL-6, TNF, phospolipase A2 and BPIP (=bacterial permeability increasing protein)

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • The Swedish Research Council

Registry information

Official study title

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

Acronym: HBP-Neupogen

Important dates

Study start
1996
Primary completion
1998
Study completion
1998
First posted
Oct 24, 2012
Registry last updated
Oct 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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