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

Acute Respiratory Failure Clinical Trial

— HBP-Neupogen  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01713309
• Other study ID #: HBP01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 14, 2012
• Last updated: October 25, 2012
• Start date: January 1996
• Est. completion date: September 1998

Study information

• Verified date: October 2012
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics CommitteeFinland: 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
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 1998
• Est. primary completion date: June 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Critical Illness
• Critically Ill
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Drug:
• Filgrastim
Filgrastim 300 ug daily for 7 days, subcutaneously.

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	The Swedish Research Council

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Pettilä 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. C — View Citation

Takala A, Pettilä 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	inflammatory mediators	cytokines, IL-6, TNF, phospolipase A2 and BPIP (=bacterial permeability increasing protein)	up to day 7	No
Primary	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.	up to 28 days	Yes
Secondary	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	Up to day 90	Yes