CompletedPhase 4ACTRN12605000060640

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.


Sponsor

Intensive care unit, Royal Darwin Hospital

Enrollment

164 participants

Start Date

Nov 3, 2003

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether G-CSF (a drug that boosts white blood cells) can improve outcomes for patients in septic shock (a life-threatening response to infection). It is for adults aged 18 and older with septic shock who meet standard diagnostic criteria. Participation involves receiving G-CSF or placebo injections.

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 thi

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)

Australia

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ACTRN12605000060640