MedDataX Logo

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

NCT ID: NCT01713309

Last Updated: 2012-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-01-31

Study Completion Date

1998-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Respiratory Failure Critically Ill

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Filgrastim G-CSF Heparin-binding protein critically ill acute respiratory failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Filgrastim

Filgrastim 300 microgr/day subcutaneously for 7 days

Group Type ACTIVE_COMPARATOR

Filgrastim

Intervention Type DRUG

Filgrastim 300 ug daily for 7 days, subcutaneously.

NaCl 0.9%

Corresponding placebo once daily, subcutaneously for 7 days

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Filgrastim

Filgrastim 300 ug daily for 7 days, subcutaneously.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Neupogen

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kirsi-Maija Kaukonen

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ville Pettila, MD, PhD

Role: STUDY_DIRECTOR

Helsinki University Central Hospital

Kirsi-Maija Kaukonen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Helsinki University Central Hospital

Helsinki, , Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 11098963 (View on PubMed)

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.

Reference Type RESULT
PMID: 15883741 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23363492 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HBP01

Identifier Type: -

Identifier Source: org_study_id