NCT01713309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 1996

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 1998

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 1998

Completed
14.1 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
Last Updated

October 29, 2012

Status Verified

October 1, 2012

Enrollment Period

2.4 years

First QC Date

October 14, 2012

Last Update Submit

October 25, 2012

Conditions

Acute Respiratory FailureCritically Ill

Keywords

FilgrastimG-CSFHeparin-binding proteincritically illacute respiratory failure

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • follow up measures

    Up to day 90

Other Outcomes (1)

  • inflammatory mediators

    up to day 7

Study Arms (2)

Filgrastim

ACTIVE COMPARATOR

Filgrastim 300 microgr/day subcutaneously for 7 days

Drug: Filgrastim

NaCl 0.9%

PLACEBO COMPARATOR

Corresponding placebo once daily, subcutaneously for 7 days

Interventions

FilgrastimDRUG

Filgrastim 300 ug daily for 7 days, subcutaneously.

Also known as: Neupogen
Filgrastim

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

Related Publications (3)

  • 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.

    PMID: 11098963RESULT

  • 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.

    PMID: 15883741RESULT

  • 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.

    PMID: 23363492DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Ville Pettila, MD, PhD

    Helsinki University Central Hospital

    STUDY DIRECTOR

  • Kirsi-Maija Kaukonen, MD, PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 14, 2012

First Posted

October 24, 2012

Study Start

January 1, 1996

Primary Completion

June 1, 1998

Study Completion

September 1, 1998

Last Updated

October 29, 2012

Record last verified: 2012-10

Locations

FI(1)