Clinical trial NCT01713309: Heparin Binding Protein in Patients With Acute Respiratory Failure Treated With GCSF (Filgrastim)
Official title: Heparin Binding Protein in Patients With Acute Respiratory Failure Treated With Granulocyte Colony-stimulating Factor (Filgrastim)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Respiratory Failure
Critically Ill
Keywords: Filgrastim
G-CSF
Heparin-binding protein
critically ill
acute respiratory failure
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
First posted: 2012-10-24
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of adverse events
timeFrame: up to 28 days
Secondary outcomes:
measure: follow up measures
timeFrame: Up to day 90
Other outcomes:
measure: inflammatory mediators
timeFrame: up to day 7
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Ville Pettila, MD, PhD
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital
name: Kirsi-Maija Kaukonen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.