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

Primary Purpose

Acute Respiratory Failure, Critically Ill

Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Filgrastim
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure focused on measuring Filgrastim, G-CSF, Heparin-binding protein, critically ill, acute respiratory failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Filgrastim

NaCl 0.9%

Arm Description

Filgrastim 300 microgr/day subcutaneously for 7 days

Corresponding placebo once daily, subcutaneously for 7 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 14, 2012
Last Updated
October 25, 2012
Sponsor
Helsinki University Central Hospital
Collaborators
The Swedish Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT01713309
Brief Title
Heparin Binding Protein in Patients With Acute Respiratory Failure Treated With GCSF (Filgrastim)
Acronym
HBP-Neupogen
Official Title
Heparin Binding Protein in Patients With Acute Respiratory Failure Treated With Granulocyte Colony-stimulating Factor (Filgrastim)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 1996 (undefined)
Primary Completion Date
June 1998 (Actual)
Study Completion Date
September 1998 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
The Swedish Research Council

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure, Critically Ill
Keywords
Filgrastim, G-CSF, Heparin-binding protein, critically ill, acute respiratory failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Filgrastim
Arm Type
Active Comparator
Arm Description
Filgrastim 300 microgr/day subcutaneously for 7 days
Arm Title
NaCl 0.9%
Arm Type
Placebo Comparator
Arm Description
Corresponding placebo once daily, subcutaneously for 7 days
Intervention Type
Drug
Intervention Name(s)
Filgrastim
Other Intervention Name(s)
Neupogen
Intervention Description
Filgrastim 300 ug daily for 7 days, subcutaneously.
Primary Outcome Measure Information:
Title
Number of adverse events
Description
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 Outcome Measure Information:
Title
follow up measures
Description
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
Other Pre-specified Outcome Measures:
Title
inflammatory mediators
Description
cytokines, IL-6, TNF, phospolipase A2 and BPIP (=bacterial permeability increasing protein)
Time Frame
up to day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ville Pettila, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kirsi-Maija Kaukonen, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
11098963
Citation
Pettila V, Takkunen O, Varpula T, Markkola A, Porkka K, Valtonen V. Safety of granulocyte colony-stimulating factor (filgrastim) in intubated patients in the intensive care unit: interim analysis of a prospective, placebo-controlled, double-blind study. Crit Care Med. 2000 Nov;28(11):3620-5. doi: 10.1097/00003246-200011000-00011.
Results Reference
result
PubMed Identifier
15883741
Citation
Takala A, Pettila V, Takkunen O, Rintala E, Kautiainen H, Repo H. Granulocyte colony-stimulating factor therapy and systemic inflammation in critically ill patients. Inflamm Res. 2005 Apr;54(4):180-5. doi: 10.1007/s00011-005-1340-2.
Results Reference
result
PubMed Identifier
23363492
Citation
Kaukonen KM, Herwald H, Lindbom L, Pettila V. Heparin binding protein in patients with acute respiratory failure treated with granulocyte colony-stimulating factor (filgrastim)--a prospective, placebo-controlled, double-blind study. BMC Infect Dis. 2013 Jan 30;13:51. doi: 10.1186/1471-2334-13-51.
Results Reference
derived

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

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