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Completed

NCT Number: NCT00252915

Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock

There is basic science evidence that GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patients with severe sepsis and septic shock.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patinets with severe sepsis and septic shock.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Severe sepsis or septic shock,
  • Presence of infection,
  • 2 SIRS criteria,
  • Acute organ dysfunction,
  • Immunoparalysis,
  • Informed consent

Exclusion criteria

  • Pregnancy,
  • Known allergies to study medication or components,
  • Moribound patient,
  • Autoimmune disease,
  • HIV-infection,
  • Acute MI or pulmonary embolism,
  • Cpr during last 72 hours,
  • Patients who participate in a different clinical study

Treatment and study plan

GM-CSF (verum)

Biological

sagramostim

Primary outcomes

  1. reconstitution of monocytic immunity as defined as a mHLA-DR expression >15,000 molecules per cell at study day 9

    Time frame: after therapy

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • German Research Foundation

Registry information

Official study title

Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock: a Prospective, Randomised, Double-blind, Placebo-controlled Study

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Nov 15, 2005
Registry last updated
May 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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