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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000060640

Acronym

N/A

Enrollment

164

Registered

2005-08-01

Start date

2003-11-03

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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

Study design

Allocation

Randomised controlled trial

Intervention model

Factorial

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Participants must fit the ACCP/SCCM Consensus Criteria for septic shock and other more recently agreed-upon non-invasive criteria. These criteria are; at least 2 signs of the presence of infection, cardiovascular failure (shock) and at least 1 sign of organ perfusion abnormality.

Exclusion criteria

Culture confirmed melioidosis, febrile neutropaenia (following chemotherapy), known haematological malignancy, myelodysplasia or congenital neutropaenia, pregnancy, known hypersensitivity to G-CSF, known objection to participate in the trial, previous transplantation, previous participation in this trial, has received G-CSF in the past month, brain death, expected survival of less than 24 hours with active orders limiting treatment and myocardial infarction in the previous 24 hours.

Outcome results