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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Verum

GM-CSF therapy

Group Type EXPERIMENTAL

GM-CSF (verum)

Intervention Type BIOLOGICAL

sagramostim

Interventions

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GM-CSF (verum)

sagramostim

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No