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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01713309
Recruitment Status : Completed
First Posted : October 24, 2012
Last Update Posted : October 29, 2012
The Swedish Research Council
Information provided by (Responsible Party):
Kirsi-Maija Kaukonen, 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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Critically Ill Drug: Filgrastim Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Heparin Binding Protein in Patients With Acute Respiratory Failure Treated With Granulocyte Colony-stimulating Factor (Filgrastim)
Study Start Date : January 1996
Actual Primary Completion Date : June 1998
Actual Study Completion Date : September 1998

Arm Intervention/treatment
Active Comparator: Filgrastim
Filgrastim 300 microgr/day subcutaneously for 7 days
Drug: Filgrastim
Filgrastim 300 ug daily for 7 days, subcutaneously.
Other Name: Neupogen

Placebo Comparator: NaCl 0.9%
Corresponding placebo once daily, subcutaneously for 7 days

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. inflammatory mediators [ Time Frame: up to day 7 ]
    cytokines, IL-6, TNF, phospolipase A2 and BPIP (=bacterial permeability increasing protein)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01713309

Helsinki University Central Hospital
Helsinki, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
The Swedish Research Council
Study Director: Ville Pettila, MD, PhD Helsinki University Central Hospital
Principal Investigator: Kirsi-Maija Kaukonen, MD, PhD Helsinki University Central Hospital

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kirsi-Maija Kaukonen, MD, PhD, Helsinki University Central Hospital Identifier: NCT01713309     History of Changes
Other Study ID Numbers: HBP01
First Posted: October 24, 2012    Key Record Dates
Last Update Posted: October 29, 2012
Last Verified: October 2012

Keywords provided by Kirsi-Maija Kaukonen, Helsinki University Central Hospital:
Heparin-binding protein
critically ill
acute respiratory failure

Additional relevant MeSH terms:
Critical Illness
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Calcium heparin
Antimicrobial Cationic Peptides
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents