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

October 25, 2012 updated by: Kirsi-Maija Kaukonen, Helsinki University Central Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Neupogen
Placebo Comparator: NaCl 0.9%
Corresponding placebo once daily, subcutaneously for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to day 90

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflammatory mediators
Time Frame: up to day 7
cytokines, IL-6, TNF, phospolipase A2 and BPIP (=bacterial permeability increasing protein)
up to day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1996

Primary Completion (Actual)

June 1, 1998

Study Completion (Actual)

September 1, 1998

Study Registration Dates

First Submitted

October 14, 2012

First Submitted That Met QC Criteria

October 22, 2012

First Posted (Estimate)

October 24, 2012

Study Record Updates

Last Update Posted (Estimate)

October 29, 2012

Last Update Submitted That Met QC Criteria

October 25, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBP01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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