A trial of G-CSF in septic shock excluding melioidosis.
A single centre double blinded randomised controlled trial of adjunctive granulocyte â¿¿ colony stimulating factor in septic shock (excluding melioidosis) to determine affects on morbidity and mortality.
Intensive care unit, Royal Darwin Hospital
164 participants
Nov 3, 2003
Interventional
Conditions
Summary
The purpose of this study is to determine whether the use of adjunctive G-CSF therapy decreases mortality and morbidity in critically ill patients with septic shock. Patients are screened for eligibility to participate in the study. If all inclusion criteria are met and there are no exclusion criteria consent is obtained from the patients or next of kin. Once consent is obtained the ICU pharmacist is contacted and the patient is randomised to receive either G-CSF or placebo once a day for 10 days or until discharge from ICU if that is sooner. Data is collected on a daily basis whilst the patient is in ICU and following discharge from ICU the date of hospital discharge or death is obtained from the hospital patient records database.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Granulocyte-colony stimulating factor is a registered drug that is already widely used. The purpose of this study is to establish the efficacy of G-CSF in septic shock. The brand of G-CSF used for this trial is Lenogastrim produced by Merck Sharp and Dome. The participants in this study are randomised to receive either G-CSF (lenogastrim 263 mcg) or placebo (normal saline), intravenously, daily for 10 days. Study drug is discontinued if the participant is discharged from the intensive care unit (ICU) before study day 10.
Locations(1)
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ACTRN12605000060640