Safety of a low-dosage Filgrastim (rhG-CSF) treatment in non-neutropenic surgical intensive care patients with an inflammatory process

Intensive Care Med. 1997 Jan;23(1):16-22. doi: 10.1007/s001340050285.

Abstract

Objective: To evaluate the effect and safety of a low dose Filgrastim treatment in surgical intensive care patients.

Design: Prospective, clinical study.

Setting: Surgical intensive care unit (ICU) in a university hospital.

Patients: Ten patients with the systemic inflammatory response syndrome (SIRS) and ten patients with sepsis were included in the study.

Interventions: Filgrastim was given intravenously at 1.0 microgram/kg for 3 days, followed by 0.5 microgram/kg for 4 days.

Measurements and results: Filgrastim treatment increased leukocyte counts and plasma levels of G-CSF. Cytokine levels (IL-6 and IL-8) decreased in the first 3 days of treatment. None of the SIRS patients developed sepsis or multiple organ failure and none of the patients died. In the sepsis group four patients died. No adverse side effects were observed, especially no attenuation of lung injury.

Conclusions: Low-dosage Filgrastim treatment in ICU patients is safe. Whether the observed changes of the inflammatory response can be attributed to Filgrastim has to be clarified in further randomized trials.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Clinical Trial, Phase II

MeSH terms

  • Cytokines / blood
  • Cytokines / drug effects
  • Female
  • Filgrastim
  • Granulocyte Colony-Stimulating Factor / administration & dosage
  • Granulocyte Colony-Stimulating Factor / blood
  • Granulocyte Colony-Stimulating Factor / drug effects
  • Granulocyte Colony-Stimulating Factor / pharmacology
  • Granulocyte Colony-Stimulating Factor / therapeutic use*
  • Humans
  • Intensive Care Units
  • Leukocyte Count / drug effects
  • Male
  • Middle Aged
  • Pilot Projects
  • Prospective Studies
  • Recombinant Proteins
  • Sepsis / drug therapy*
  • Systemic Inflammatory Response Syndrome / drug therapy*

Substances

  • Cytokines
  • Recombinant Proteins
  • Granulocyte Colony-Stimulating Factor
  • Filgrastim