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

This study has been completed.
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by (Responsible Party):
Kirsi-Maija Kaukonen, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01713309
First received: October 14, 2012
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Acute Respiratory Failure
Critically Ill
Drug: Filgrastim
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Heparin Binding Protein in Patients With Acute Respiratory Failure Treated With Granulocyte Colony-stimulating Factor (Filgrastim)

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]
    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:
  • follow up measures [ Time Frame: Up to day 90 ] [ Designated as safety issue: Yes ]
    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:
  • inflammatory mediators [ Time Frame: up to day 7 ] [ Designated as safety issue: No ]
    cytokines, IL-6, TNF, phospolipase A2 and BPIP (=bacterial permeability increasing protein)


Enrollment: 59
Study Start Date: January 1996
Study Completion Date: September 1998
Primary Completion Date: June 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713309

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kirsi-Maija Kaukonen, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01713309     History of Changes
Other Study ID Numbers: HBP01
Study First Received: October 14, 2012
Last Updated: October 25, 2012
Health Authority: Finland: Ethics Committee
Finland: National Agency of Medicines 17 Dec 1996/ Dno: 287/853/96 (the name on your listing is the name the agency has today. In 1996 it was National Agency of Medicines)
Finland: Finnish Medicines Agency

Keywords provided by Helsinki University Central Hospital:
Filgrastim
G-CSF
Heparin-binding protein
critically ill
acute respiratory failure

Additional relevant MeSH terms:
Critical Illness
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Disease Attributes
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Heparin
Lenograstim
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014